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

Model Number	M00510880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of basket wire break.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.It was reported that during the procedure "the basket wire could be broken".The procedure was completed using another trapezoid rx.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h2: additional information block b5 has been updated.Block h6: imdrf device code a0401 captures the reportable event of basket wire break.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.It was reported that during the procedure "the basket wire could be broken".The procedure was completed using another trapezoid rx.There were no patient complications as a result of this event.Additional information received on january 08, 2026 the tip of the basket was intentionally detached.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of basket wire break.Block h11: investigation results: the device was not returned for analysis; it was discarded; therefore, a technical analysis could not be performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of basket wire break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.It was reported that during the procedure "the basket wire could be broken".The procedure was completed using another trapezoid rx.There were no patient complications as a result of this event.Additional information received on january 08, 2026.The tip of the basket was intentionally detached.

• 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: 23990984
• Report Number: 3005099803-2026-00084
• Device Sequence Number: 10523200
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: (01)08714729296393(17)260829(10)37335179
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/31/2026

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: 08/29/2026
• Device Model Number: M00510880
• Device Catalogue Number: M00510880
• Device Lot Number: 0037335179
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 03/10/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/03/2026; 03/31/2026
• Date Device Manufactured: 08/29/2025
• 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