FDA Adverse Event
Malfunction
Summary report: N
CRE BALLOON DILATATION CATHETER
MDR report key: 1171358
·
Received September 17, 2008
Report
- Report Number
- 3005099803-2008-04622
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- August 18, 2008
- Report Date
- August 21, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- KNQ
- PMA / PMN Number
- K974788
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNSPECIFIED GASTRO-INTESTINAL (GI) PROCEDURE, A BALLOON LEAK AND INFLATION DIFFICULTIES WERE ENCOUNTERED. THE LOCATION OF THE LESION WAS UNKNOWN. THE CRE 15MM X 18MM BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND INFLATED THE FIRST TIME WITHOUT DIFFICULTY. ON THE SECOND INFLATION, THE BALLOON FAILED TO INFLATE AND A LEAK WAS NOTED. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRE BALLOON DILATATION CATHETER | KNQ | BOSTON SCIENTIFIC | M00558430 | 11635232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |