FDA Adverse Event
Malfunction
Summary report: N
CRE BALLOON CATHETER
MDR report key: 1193275
·
Received October 7, 2008
Report
- Report Number
- 3005099803-2008-05085
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 8, 2008
- Report Date
- September 9, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- KNQ
- PMA / PMN Number
- K971320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNSPECIFIED ENDOSCOPY PROCEDURE, THE BALLOON FAILED TO HOLD PRESSURE. A CRE 10-12MM 8CM F/G BALLOON CATHETER HAD BEEN ADVANCED TO AN UNSPECIFIED LOCATION. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE BALLOON FAILED TO HOLD PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "STABLE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRE BALLOON CATHETER | KNQ | BOSTON SCIENTIFIC | M00558350 | 0011782686 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |