INTRA-AORTIC BALLOON
This device is manufactured by DATASCOPE CORP.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Stroke/CVA | 1 | Patient |
| 2024 | Myocardial Infarction | 2 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Unraveled Material | 1 | Device |
| 2024 | Restricted Flow rate | 1 | Device |
| 2024 | Pressure Problem | 1 | Device |
| 2024 | Optical Problem | 16 | Device |
| 2024 | No Apparent Adverse Event | 1 | Device |
| 2024 | Migration | 2 | Device |
| 2024 | Material Puncture/Hole | 1 | Device |
| 2024 | Material Deformation | 4 | Device |
| 2024 | Leak/Splash | 6 | Device |
| 2024 | Inflation Problem | 1 | Device |
| 2024 | Incomplete or Missing Packaging | 2 | Device |
| 2024 | Inappropriate Waveform | 1 | Device |
| 2024 | Inability to Auto-Fill | 3 | Device |
| 2024 | Gas/Air Leak | 1 | Device |
| 2024 | Difficult to Insert | 4 | Device |
| 2024 | Difficult to Advance | 2 | Device |
| 2024 | Calibration Problem | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Pulmonary Embolism | 1 | Patient |
| 2023 | Myocardial Infarction | 1 | Patient |
| 2023 | Cardiomyopathy | 1 | Patient |
| 2023 | Cardiogenic Shock | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 2 | Patient |
| 2023 | Air Embolism | 1 | Patient |
| 2023 | Unraveled Material | 3 | Device |
| 2023 | Restricted Flow rate | 2 | Device |
| 2023 | Pressure Problem | 4 | Device |
| 2023 | Optical Problem | 22 | Device |
| 2023 | Obstruction of Flow | 1 | Device |
| 2023 | No Apparent Adverse Event | 2 | Device |
| 2023 | Migration | 2 | Device |
| 2023 | Material Puncture/Hole | 1 | Device |
| 2023 | Material Deformation | 2 | Device |
| 2023 | Leak/Splash | 6 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Inflation Problem | 2 | Device |
| 2023 | Inappropriate Waveform | 5 | Device |
| 2023 | Inability to Auto-Fill | 5 | Device |
| 2023 | Gas/Air Leak | 4 | Device |
| 2023 | Failure to Advance | 1 | Device |
| 2023 | Difficult to Insert | 9 | Device |
| 2023 | Difficult to Flush | 1 | Device |
| 2023 | Difficult to Advance | 2 | Device |
| 2023 | Device Alarm System | 3 | Device |
| 2023 | Crack | 2 | Device |
| 2023 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2023 | Calibration Problem | 1 | Device |
| 2023 | Break | 1 | Device |
| 2022 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Unraveled Material | 1 | Device |
| 2022 | Restricted Flow rate | 1 | Device |
| 2022 | Pressure Problem | 7 | Device |
| 2022 | Optical Problem | 19 | Device |
| 2022 | No Apparent Adverse Event | 2 | Device |
| 2022 | Migration | 1 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Deformation | 5 | Device |
| 2022 | Leak/Splash | 10 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Inflation Problem | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Inappropriate Waveform | 6 | Device |
| 2022 | Inability to Auto-Fill | 6 | Device |
| 2022 | Gas/Air Leak | 4 | Device |
| 2022 | Difficult to Insert | 5 | Device |
| 2022 | Calibration Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Use of Device Problem | 1 | Device |
| 2019 | Unstable | 1 | Device |
| 2019 | Unraveled Material | 3 | Device |
| 2019 | Unexpected Therapeutic Results | 1 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 4 | Device |
| 2019 | Protective Measures Problem | 3 | Device |
| 2019 | Pressure Problem | 10 | Device |
| 2019 | Output Problem | 1 | Device |
| 2019 | Optical Problem | 21 | Device |
| 2019 | Obstruction of Flow | 5 | Device |
| 2019 | Noise, Audible | 1 | Device |
| 2019 | No Display/Image | 1 | Device |
| 2019 | Moisture or Humidity Problem | 2 | Device |
| 2019 | Moisture Damage | 3 | Device |
| 2019 | Migration or Expulsion of Device | 1 | Device |
| 2019 | Material Deformation | 7 | Device |
| 2019 | Leak/Splash | 17 | Device |
| 2019 | Inflation Problem | 6 | Device |
| 2019 | Incorrect, Inadequate or Imprecise Result or Readings | 2 | Device |
| 2019 | Inability to Auto-Fill | 1 | Device |
| 2019 | Improper Flow or Infusion | 1 | Device |
| 2019 | Gas/Air Leak | 8 | Device |
| 2019 | Flushing Problem | 2 | Device |
| 2019 | Fluid/Blood Leak | 2 | Device |
| 2019 | Filling Problem | 5 | Device |
| 2019 | Failure to Unfold or Unwrap | 1 | Device |
| 2019 | Failure to Sense | 1 | Device |
| 2019 | Failure to Advance | 1 | Device |
| 2019 | Energy Output Problem | 1 | Device |
| 2019 | Display or Visual Feedback Problem | 7 | Device |
| 2019 | Display Difficult to Read | 1 | Device |
| 2019 | Difficult to Remove | 4 | Device |
| 2019 | Difficult to Insert | 12 | Device |
| 2019 | Difficult to Flush | 2 | Device |
| 2019 | Difficult to Advance | 3 | Device |
| 2019 | Device Sensing Problem | 2 | Device |
| 2019 | Device Displays Incorrect Message | 6 | Device |
| 2019 | Device Damaged Prior to Use | 6 | Device |
| 2019 | Device Contamination with Chemical or Other Material | 34 | Device |
| 2019 | Device Alarm System | 1 | Device |
| 2019 | Deformation Due to Compressive Stress | 1 | Device |
| 2019 | Defective Device | 1 | Device |
| 2019 | Defective Component | 2 | Device |
| 2019 | Coagulation in Device or Device Ingredient | 1 | Device |
| 2019 | Calibration Problem | 5 | Device |
| 2019 | Backflow | 2 | Device |
| 2019 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2018 | Wrinkled | 1 | Device |
| 2018 | Unraveled Material | 4 | Device |
| 2018 | Uncoiled | 3 | Device |
| 2018 | Temperature Problem | 1 | Device |
| 2018 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2018 | Suction Problem | 1 | Device |
| 2018 | Self-Activation or Keying | 1 | Device |
| 2018 | Reflux within Device | 1 | Device |
| 2018 | Pressure Problem | 5 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Physical Resistance | 1 | Device |
| 2018 | Packaging Problem | 1 | Device |
| 2018 | Output Problem | 2 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | No Display/Image | 1 | Device |
| 2018 | Moisture or Humidity Problem | 1 | Device |
| 2018 | Moisture Damage | 2 | Device |
| 2018 | Mechanical Problem | 1 | Device |
| 2018 | Material Twisted/Bent | 1 | Device |
| 2018 | Material Rupture | 9 | Device |
| 2018 | Material Perforation | 1 | Device |
| 2018 | Material Disintegration | 1 | Device |
| 2018 | Material Deformation | 7 | Device |
| 2018 | Leak/Splash | 8 | Device |
| 2018 | Kinked | 1 | Device |
| 2018 | Infusion or Flow Problem | 1 | Device |
| 2018 | Inflation Problem | 4 | Device |
| 2018 | Inability to Auto-Fill | 7 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Improper Flow or Infusion | 1 | Device |
| 2018 | Hole In Material | 3 | Device |
| 2018 | Gas/Air Leak | 1 | Device |
| 2018 | Fluid/Blood Leak | 5 | Device |
| 2018 | Fitting Problem | 4 | Device |
| 2018 | Failure to Sense | 3 | Device |
| 2018 | Failure to Select Signal | 1 | Device |
| 2018 | Failure to Pump | 2 | Device |
| 2018 | Failure to Deliver | 1 | Device |
| 2018 | Failure to Calibrate | 5 | Device |
| 2018 | Failure to Advance | 17 | Device |
| 2018 | Display or Visual Feedback Problem | 7 | Device |
| 2018 | Disconnection | 3 | Device |
| 2018 | Difficult to Insert | 8 | Device |
| 2018 | Difficult to Advance | 2 | Device |
| 2018 | Device Packaging Compromised | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 5 | Device |
| 2018 | Device Markings/Labelling Problem | 1 | Device |
| 2018 | Device Displays Incorrect Message | 43 | Device |
| 2018 | Device Contamination with Body Fluid | 1 | Device |
| 2018 | Device Alarm System | 1 | Device |
| 2018 | Delivered as Unsterile Product | 1 | Device |
| 2018 | Deformation Due to Compressive Stress | 4 | Device |
| 2018 | Deflation Problem | 2 | Device |
| 2018 | Defective Device | 2 | Device |
| 2018 | Defective Component | 2 | Device |
| 2018 | Defective Alarm | 1 | Device |
| 2018 | Component Missing | 1 | Device |
| 2018 | Calibration Problem | 3 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Backflow | 2 | Device |
| 2018 | Aspiration Issue | 1 | Device |
| 2018 | Appropriate Term/Code Not Available | 5 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2017 | Unraveled Material | 1 | Device |
| 2017 | Torn Material | 1 | Device |
| 2017 | Sticking | 3 | Device |
| 2017 | Pressure Problem | 3 | Device |
| 2017 | Positioning Problem | 2 | Device |
| 2017 | Physical Resistance | 2 | Device |
| 2017 | Operating System Becomes Nonfunctional | 1 | Device |
| 2017 | Noise, Audible | 1 | Device |
| 2017 | Moisture or Humidity Problem | 18 | Device |
| 2017 | Moisture Damage | 20 | Device |
| 2017 | Material Rupture | 4 | Device |
| 2017 | Leak/Splash | 6 | Device |
| 2017 | Kinked | 2 | Device |
| 2017 | Inflation Problem | 4 | Device |
| 2017 | Inability to Auto-Fill | 1 | Device |
| 2017 | Improper Flow or Infusion | 1 | Device |
| 2017 | Hole In Material | 1 | Device |
| 2017 | Gas Output Problem | 1 | Device |
| 2017 | Fracture | 1 | Device |
| 2017 | Folded | 1 | Device |
| 2017 | Flushing Problem | 1 | Device |
| 2017 | Fluid/Blood Leak | 8 | Device |
| 2017 | Failure to Sense | 2 | Device |
| 2017 | Failure to Calibrate | 2 | Device |
| 2017 | Failure to Align | 1 | Device |
| 2017 | Failure to Advance | 10 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Difficult to Insert | 6 | Device |
| 2017 | Difficult to Advance | 1 | Device |
| 2017 | Device Packaging Compromised | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 11 | Device |
| 2017 | Device Displays Incorrect Message | 25 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Device Contamination with Body Fluid | 3 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Bent | 1 | Device |
| 2017 | Backflow | 1 | Device |
| 2017 | Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Torn Material | 3 | Device |
| 2016 | Noise, Audible | 1 | Device |
| 2016 | Leak/Splash | 1 | Device |
| 2016 | Insufficient Information | 1 | Device |
| 2016 | Improper Flow or Infusion | 1 | Device |
| 2016 | Gas/Air Leak | 1 | Device |
| 2016 | Display or Visual Feedback Problem | 1 | Device |
| 2016 | Difficult to Remove | 1 | Device |
| 2016 | Difficult or Delayed Positioning | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 2 | Device |
| 2016 | Device Displays Incorrect Message | 6 | Device |
| 2016 | Device Contamination with Body Fluid | 2 | Device |
| 2016 | Air Leak | 2 | Device |
| 2016 | Activation, Positioning or Separation Problem | 1 | Device |
| 2015 | Device Displays Incorrect Message | 1 | Device |
| 2013 | Leak/Splash | 1 | Device |
| 2012 | Difficult to Insert | 1 | Device |