FDA Adverse Event
Malfunction
Summary report: N
BLUE MAX BALLOON DILATATION CATHETER
MDR report key: 2923302
·
Received March 25, 2006
Report
- Report Number
- 6000093-2006-02723
- Event Type
- Malfunction
- Date Received
- March 25, 2006
- Date of Event
- February 23, 2006
- Report Date
- February 24, 2006
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS, BUT REQUIRES ADDITIONAL INVESTIGATION WHICH IS NOT COMPLETE AT THIS TIME.
Description of Event or Problem · 1
SAME CASE AS MFR'S REPORT # 6000089-2006-00502. IT WAS REPORTED THAT DURING A TIPS TREATMENT PROCEDURE, THE BALLOON WOULD NOT COME OUT OF THE SHEATH. THE BLUE MAX/12-4/7/75 BALLOON WAS REPLACED WITH ANOTHER OF THE SAME, WITH THE SAME RESULT. THE LESION BEING TREATED WAS LOCATED IN THE LIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD BLUE MAX/12-4/7/75 BALLOON. THERE WERE NO PT COMPLICATIONS AND THE CURRENT PT STATUS IS REPORTED AS 'FINE' FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLUE MAX BALLOON DILATATION CATHETER | PTA BALLOON DILATATION CATHETER | FGE | BOSTON SCIENTIFIC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |