FDA Adverse Event
Injury
Summary report: N
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET
MDR report key: 1161296
·
Received September 15, 2008
Report
- Report Number
- 3005099803-2008-04574
- Event Type
- Injury
- Date Received
- September 15, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 21, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- LQC
- PMA / PMN Number
- K040447
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A BILIARY STONE TREATMENT PROCEDURE THE TIP DISLODGED INSIDE THE PATIENT AND THE HANDLE BROKE. THE TARGET STONES WERE IN THE COMMON BILE DUCT (CBD). AN RX LITHOTRIPTER BASKET HAD BEEN ADVANCED TO THE TARGET STONES. THE BASKET WAS ATTACHED TO AN ALLIANCE DEVICE TO AID IN CRUSHING THE STONES. THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT AND THE BASKET HANDLE BROKE OUTSIDE THE PATIENT. THE DETACHED TIP WAS LODGED IN THE DUODENUM. THE PROCEDURE WAS CONSIDERED TO BE COMPLETED WITH THIS DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. "THE PHYSICIAN HAS BEEN FOLLOWING UP THE PATIENT CONDITION." THE PATIENT'S CURRENT CONDITION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET | LQC | BOSTON SCIENTIFIC | M00510890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |