FDA Adverse Event
Death
Summary report: N
MEMORY SOFT WIRE BASKET
MDR report key: 62697
·
Received January 9, 1997
Report
- Report Number
- 1037905-1997-00001
- Event Type
- Death
- Date Received
- January 9, 1997
- Date of Event
- November 22, 1996
- Report Date
- December 9, 1996
- Manufacturer
- WILSON-COOK MEDICAL INC.
- Product Code
- FFL
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
THE PHYSICIAN PERFORMED AN ERCP AND STONE REMOVAL WITH A SOFT WIRE BASKET. THE BASKET WAS PLACED INTO THE COMMON BILE DUCT; HOWEVER, DURING THE PROCEDURE THE BASKET WOULD NOT RETRACT. THE PATIENT WAS TAKEN TO SURGERY WHERE THE BASKET WAS REMOVED. THE PATIENT HAS SINCE THEN EXPIRED; HOWEVER, IT WAS NOTED THE DEATH WAS NOT DIRECTLY RELATED TO THE INCIDENT. NO FURTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEMORY SOFT WIRE BASKET | SOFT WIRE BASKET | FFL | WILSON-COOK MEDICAL INC. | NA | 1044359 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |