MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number	M00510880
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device codes a0401 captures the reportable event of handle cannula break based on investigation findings.Block h11: the trapezoid rx lithotripter basket was returned for analysis.Visual inspection found that the handle cannula was broken, the working length was kinked in several areas, and the side car rx was pushed back 4mm.It was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the available information, boston scientific confirmed the reported event of basket failure to open.The observed side car rx pushed back could have been due to force applied to the thumb ring on the handle when attempting to break the stone.This force could have also caused the working length to retract, thereby pushing back the side car rx.Also, it was possible that the same force and pressure applied on the handle caused the entire device to retract.The force applied during the attempt to break the stone could have subjected the device to significant stress, causing the handle cannula to break and the working length to kink, preventing the basket from opening as reported.No other damage was noted to the device.Based on the available information and findings from the device evaluation, the most probable cause selected is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that trapezoid rx basket was used in the common bile duct to capture a stone during stone removal procedure performed on (b)(6) 2025.During the procedure, it was reported that the basket would not open in the common bile duct.It was also reported that there was a stone outside the basket when it failed to open.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the investigation finding of handle cannula detached or separated.Please see device analysis results for full investigation details.

• Brand Name: TRAPEZOID RX
• Common Device Name: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25033783
• Report Number: 3005099803-2026-01573
• Device Sequence Number: 9323008
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: (01)08714729296393(17)260514(10)36518455
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K040447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2026
• Device Model Number: M00510880
• Device Catalogue Number: M00510880
• Device Lot Number: 0036518455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown