FDA Adverse Event
Malfunction
Summary report: N
F/G GATEWAY OTW US 9 X 2.5
MDR report key: 2892387
·
Received January 2, 2013
Report
- Report Number
- 3008853977-2013-00004
- Event Type
- Malfunction
- Date Received
- January 2, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 21, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MINN
- Product Code
- GBA
- PMA / PMN Number
- H050001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS PREPARING THE BALLOON CATHETER TO PERFORM A STENT ASSISTED ANGIOPLASTY PROCEDURE, A "HISSING" SOUND WAS HEARD FROM THE BALLOON AS AIR WAS BEING ASPIRATED WITH THE SYRINGE. THE PHYSICIAN DECIDED TO USE ANOTHER BALLOON CATHETER (SUBJECT DEVICE) AND ENCOUNTERED THE SAME ISSUE. ANOTHER OF THE SIMILAR DEVICE WAS PREPARED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1144 | F/G GATEWAY OTW US 9 X 2.5 | CATHETER, BALLOON TYPE | GBA | BOSTON SCIENTIFIC - MINN | N/A | 15293179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC) |