FDA Adverse Event
Injury
Summary report: N
COOK, INC.
MDR report key: 236988
·
Received August 23, 1999
Report
- Report Number
- 236988
- Event Type
- Injury
- Date Received
- August 23, 1999
- Date of Event
- August 5, 1999
- Report Date
- August 20, 1999
- Manufacturer
- COOK, INC.
- Product Code
- DQX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT GETTING PERCUTANEOUS NEPHROSTOMY UNDER FLUOROSCOPY USING A GUIDE WIRE. WHEN ATTEMPTED TO REMOVE GUIDE WIRE IT BROKE AT THE SOLDER POINT, LEAVING ABOUT 2.5 INCHES IN THE PT'S KIDNEY. ATTEMPTS TO SNARE REMAINING WIRE WERE UNSUCCESSFUL. PT TO UNDERGO LAPAROSCOPIC SURGERY TO REMOVE REMAINING WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COOK, INC. | MANDRIL GUIDE WIRE | DQX | COOK, INC. | * | 906481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| O |