FDA Adverse Event
Malfunction
Summary report: N
IAB: 8 FR - 40CC
MDR report key: 1022881
·
Received March 28, 2008
Report
- Report Number
- 1219856-2008-00152
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 28, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K970689
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED, BY THE CUSTOMER, THAT A SHEATHED BALLOON WAS INSERTED VIA THE FEMORAL VEIN. AS PER PERFUSION: SQUARE BALLOON PRESSURE WAVEFORM 6 BEATS, NO ALARMS. BLOOD PRESSURE 40, LOWER THAN EXPECTED. BLOOD IN GAS LINE. IT IS POSSIBLE THAT THE BALLOON NEVER ENTERED INTO THE AORTA. AS A RESULT, ANOTHER BALLOON WAS NOT INSERTED AS THE PT EXPIRED DUE TO OTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 8 FR - 40CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | MF7097226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |