FDA Adverse Event
Malfunction
Summary report: N
C.R.E. ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER
MDR report key: 1081520
·
Received July 25, 2008
Report
- Report Number
- 3005099803-2008-01282
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- June 25, 2008
- Report Date
- June 25, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORK LTD.
- Product Code
- KNQ
- PMA / PMN Number
- K974788
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNSPECIFIED BILIARY PROCEDURE, THE BALLOON BURST. THE CRE BALLOON DILATION CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS REPORTED TO BE GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C.R.E. ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER | KNQ - BALLOON DILATATION CATHETER | KNQ | BOSTON SCIENTIFIC CORK LTD. | M00558420 | 11563348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |