FDA Adverse Event
Malfunction
Summary report: N
FOX SV PTA CATHETER
MDR report key: 1160019
·
Received September 12, 2008
Report
- Report Number
- 9710478-2008-00109
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 22, 2008
- Report Date
- August 25, 2008
- Manufacturer
- ABBOTT VASCULAR SWITZERLAND
- Product Code
- LIT
- PMA / PMN Number
- K062843
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.
Description of Event or Problem · 1
DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE FOX SV BALLOON CATHETER RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION. THE BALLOON AND DELIVERY CATHETER WERE REMOVED FROM THE BODY, AND THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOX SV PTA CATHETER | LIT | ABBOTT VASCULAR SWITZERLAND | NA | 471548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | TREASURE GUIDE WIRE| PARENT SHEATH |