FDA Adverse Event
Malfunction
Summary report: N
TRAPEZOID RX
MDR report key: 24942608
·
Received April 21, 2026
Report
- Report Number
- 3005099803-2026-01459
- Event Type
- Malfunction
- Date Received
- April 21, 2026
- Date of Event
- March 24, 2026
- Report Date
- April 21, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LQC
- UDI-DI
- 08714729296409
- PMA / PMN Number
- K040447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A150301 CAPTURES THE REPORTABLE EVENT TIP FAILURE TO SEPARATE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER BASKET WAS USED IN THE COMMON BILE DUCT FOR BILE DUCT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE MECHANICAL LITHOTRIPSY WAS PERFORMED, AND THE TIP WAS DIRECTLY DAMAGED AND STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1007073 | TRAPEZOID RX | LITHOTRIPTOR, BILIARY MECHANICAL | LQC | BOSTON SCIENTIFIC CORPORATION | M00510890 | 0037654133 | 08714729296409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |