FDA Adverse Event
Injury
Summary report: N
COOK INC. FUSION QUATTRO EXTRACTION BALLOON
MDR report key: 19143165
·
Received April 18, 2024
Report
- Report Number
- MW5154011
- Event Type
- Injury
- Date Received
- April 18, 2024
- Date of Event
- April 12, 2024
- Report Date
- April 16, 2024
- Manufacturer
- COOK MEDICAL/WILSON-COOK MEDICAL INC.
- Product Code
- GCA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT HAD AN ERCP FOR COMMON BILE DUCT STONES. COOK FUSION QUATTRO EXTRACTION BALLOON WAS USED FOR STONE SWEEP AND UPON INFLATION THE BALLOON RUPTURED. AN ADDITIONAL EXTRACTION BALLOON WAS UTILIZED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY COMPLICATIONS OR PATIENT HARM. COOK FUSION QUATTRO EXTRACTION BALLOON: 8.5/10/12/15 MM, REF: FS-QEB-B, LOT#: W4725370, EXP: 05/08/2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2584347 | COOK INC. FUSION QUATTRO EXTRACTION BALLOON | BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRA | GCA | COOK MEDICAL/WILSON-COOK MEDICAL INC. | FS-QEB-B | W4725370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Female | Required Intervention |