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

Model Number	M00510870
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of handle break.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During procedure, the handle of the trapezoid rx was broken during the attachment to the alliance gun.Another trapezoid rx was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of handle break.Block h11: the returned trapezoid rx was analyzed, and a visual inspection found the guide side car rx was pushed back 2mm.The sheath was found detached and accordioned.Functional test was performed, and the basket was found able to open and close.The handle was not broken.With all the available information, boston scientific concludes that the reported event was not confirmed.During analysis, the handle was observed in good condition and a functional test found the basket was able to open and close, which indicates that the handle is functioning properly.Therefore, this reported issue will be classified as "no problem detected".On the other hand, the side car rx was found pushed back.This issue could be caused due to the amount of force applied on the thumb ring from the handle when trying to destroy the stone.And by this force applied, the working length tends to "retract" itself and therefore, pushing back the side car rx.There is also a possibility that the same force applied when trying to destroy the stone made the whole device retract itself from the force applied on the handle and detaching the sheath as a result, also getting the sheath buckled before it couldn't handle the pressure it was used with and got detached.Therefore, all the issues found will be classified as "adverse event related to procedure".Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event is "adverse event related to procedure" since the adverse events occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During procedure, the handle of the trapezoid rx was broken during the attachment to the alliance gun.Another trapezoid rx was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 24158817
• Report Number: 3005099803-2026-00280
• Device Sequence Number: 13078660
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: (01)08714729296386(17)260610(10)36721370
• 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,Followup
• Report Date (Section B): 03/16/2026

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: 06/10/2026
• Device Model Number: M00510870
• Device Catalogue Number: M00510870
• Device Lot Number: 0036721370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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