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

Model Number	M00510870
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event side car rx torn material.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During preparation, it was observed that there was a crack near the rx port, causing the guidewire to come out through the crack.The procedure was completed with another of the same device.There were no patient complications reported 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: 25176417
• Report Number: 3005099803-2026-01901
• Device Sequence Number: 18797680
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: (01)08714729296386(17)261006(10)37627118
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/11/2026

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 Model Number: M00510870
• Device Catalogue Number: M00510870
• Device Lot Number: 0037627118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/11/2026
• Date Device Manufactured: 10/06/2025
• 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