FDA Adverse Event
Malfunction
Summary report: N
FOX SV PTA CATHETER
MDR report key: 1221556
·
Received November 5, 2008
Report
- Report Number
- 9710478-2008-00153
- Event Type
- Malfunction
- Date Received
- November 5, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 15, 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
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE.
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 POPLITEAL ARTERY, THE FOX SV BALLOON RUPTURED BELOW RATED BURST PRESSURE. 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 | 386417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |