FDA Adverse Event
Malfunction
Summary report: N
IAB: 8 FR - 40 CC
MDR report key: 1172858
·
Received September 19, 2008
Report
- Report Number
- 1219856-2008-00445
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- September 8, 2008
- Report Date
- September 19, 2008
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DSP
- PMA / PMN Number
- K970689
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FIELD IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED. THE MD INSERTED THE IAB VIA A SHEATH INTO THE FEMORAL ARTERY. AFTER PLACEMENT, THE PERFUSIONIST NOTICED THAT THERE WAS A CRACK ON THE HUB AT THE DISTAL END OF THE EXTENSION LINE. THE PERFUSIONIST "TIGHTENED AND PLACED OPSITE (TRANSPARENT ADHESIVE DRESSING) TO PREVENT FURTHER LEAKING." THE IAB "FUNCTIONED PERFECTLY WELL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 8 FR - 40 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTERNATIONAL INC. | MF7097470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |