FDA Adverse Event
Malfunction
Summary report: N
FOX PLUS PTA CATHETER
MDR report key: 1230397
·
Received November 7, 2008
Report
- Report Number
- 9710478-2008-00154
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 14, 2008
- Report Date
- October 17, 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
- KS, 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 ILIAC ARTERY, THE FOX PLUS BALLOON RUPTURED AT 3 ATMOSPHERES. DILATATION WAS COMPLETED USING A NON-ABBOTT BALLOON. 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 PLUS PTA CATHETER | LIT | ABBOTT VASCULAR SWITZERLAND | NA | 537617 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | ADMIRAL 7X40 DILATATION CATHETER |