FDA Adverse Event
Summary report: N
TRAPEZOID RX
MDR report key: 2182618
·
Received July 15, 2011
Report
- Report Number
- 2182618
- Date Received
- July 15, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 15, 2011
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LQC
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PT WAS IN FOR PANCREATIC STONE REMOVAL. THE BASKET PASSED INTO THE PANCREATIC DUCT AND THE STONE WAS CAPTURED IN THE BASKET. THE BASKET CLOSED AND ATTEMPTED TO CRUSH STONE. UNABLE TO CRUSH STONE. IN THE PROCESS OF CLOSING THE BASKET, THE WIRES BROKE LEAVING THE BASKET INSIDE OF THE PANCREATIC DUCT AROUND THE STONE AND WIRES OUT INTO THE DUODENUM. MULTIPLE ATTEMPTS OF RETRIEVAL WERE UNSUCCESSFUL. THE PT WAS ADMITTED AND WILL ATTEMPT RETRIEVAL AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRAPEZOID RX | TRAPEZOID RX | LQC | BOSTON SCIENTIFIC | 1086 | 14052433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |