FDA Adverse Event
Malfunction
Summary report: N
DSB - DETACHABLE SILICONE BALLOON
MDR report key: 375288
·
Received January 30, 2002
Report
- Report Number
- 6000078-2001-00130
- Event Type
- Malfunction
- Date Received
- January 30, 2002
- Date of Event
- December 31, 2001
- Report Date
- January 29, 2002
- Manufacturer
- TARGET THERAPEUTICS / A DIVISION OF BOSTON SCIENTIFIC CORPORATION
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BSC/TARGET THAT "AFTER DETACHING THE INFLATED BALLOON PART # 771592 INSIDE THE THE FISTULA, THE BALLOON DEFLATED AFTER 5 MINUTES. OPENING THE FISTULA AGAIN, A SECOND INFLATED BALLOON PART # 771852 WAS DETACHED. AGAIN THE BALLOON DEFLATED AFTER 10 MINUTES OF DETACHMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DSB - DETACHABLE SILICONE BALLOON | DETACHABLE BALLOON | HCG | TARGET THERAPEUTICS / A DIVISION OF BOSTON SCIENTIFIC CORPORATION | * | 3998418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | OXID. CATHETER, BRAND NAME: VENT MANDREL, BRAND| DATE: 2001.| BRAND NAME: GUIDER 8F CATHETER, BRAND NAME: CO-| NAME: DETACHABLE SILICON BALLOON, CATALOG #:771592| LOT#:4088165, EXPIRATION DATE:12/31/2003, IMPLANT| MANDREL, DETACHABLE SILICON BALLOON, 771592, |