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

Model Number	M00510880
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
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 performed on (b)(6) 2026.During the procedure, the handle cannula broke when trying to crush a stone approximately 1cm.The basket was pulled out of the scope.Procedure was prolonged by less than 5 minutes and was completed with an extractor balloon 9-12mm.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 cannula 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 performed on (b)(6) 2026.During the procedure, the handle cannula broke when trying to crush a stone approximately 1cm.The basket was pulled out of the scope.Procedure was prolonged by less than 5 minutes and was completed with an extractor balloon 9-12mm.There were no patient complications as a result of this event.Additional information received on march 9, 2026 the basket failed to crush the stone when the handle cannula broke.However, the stone was able to be slipped out of the basket.
Additional Manufacturer Narrative
Block b5 and h6 (device codes) has been updated based on the additional information received on march 9, 2026.Block h6: imdrf device code a0401 captures the reportable event of handle cannula break.Block h11: the device was not returned for analysis and was disposed; therefore, a technical analysis could not be performed.It was confirmed that 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 "handle cannula break" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the event description and information provided by the customer there is not enough evidence to determine whether the handle cannula break was due to the physician's technique during the procedure or was related to a device malfunction.For this reason, "unable to exclude device problem" is selected as the most probable cause for this event.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.All compiled information on this investigation determines that the most probable cause is "unable to exclude device problem".

• 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: 24461807
• Report Number: 3005099803-2026-00754
• Device Sequence Number: 9403602
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: (01)08714729296393(17)261201(10)38078736
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2026

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: M00510880
• Device Catalogue Number: M00510880
• Device Lot Number: 0038078736
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/15/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/31/2026; 05/08/2026
• Date Device Manufactured: 12/01/2025
• 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