FDA Adverse Event
Injury
Summary report: N
ARROW/BARD 9FR INTRA-AORTIC BALLOON
MDR report key: 238250
·
Received August 30, 1999
Report
- Report Number
- 1219856-1999-00257
- Event Type
- Injury
- Date Received
- August 30, 1999
- Report Date
- August 26, 1999
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT 2 HRS AFTER THE IAB WAS INSERTED, THE PUMP BEGAN EXPERIENCING HELIUM LOSS ALARMS. THE IAB WAS REMOVED AND REPLACED WITHOUT ANU COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARROW/BARD 9FR INTRA-AORTIC BALLOON | INTRA-AORTIC BALLOON | DSP | ARROW INTL., INC. | NA | 13II0018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |