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); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
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 a mechanical lithotripsy procedure performed on (b)(6) 2028.During procedure, when using the alliance handle, the handle cannula snapped instead of the basket tip breaking off.The stone fortunately fell out of the basket.A different device and a plastic stent were used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: block a0401 captures the reportable event of handle cannula break.Block a150301 captures the reportable event of tip failure to separate.Block a23 captures the reportable event of basket failure to crush stone.Block f2301 captures the additional device of alliance handle to crush the stone.Block h11: the device 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 labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.A risk review performed for the lithotripter baskets device confirmed that the events of handle cannula break, tip failure to separate, and basket failure to crush stone are known events defined in the product's risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the lithotripter baskets device is acceptable.Based on all available information, there is not enough evidence to determine whether the handle cannula break, tip failure to separate, and basket failure to crush stone were due to the physician's manipulation of the device during the procedure or related to a device malfunction.Without proper evaluation of the device, it remains unknown the most probable cause that contributed to the events.On the other hand, for the event additional device required, it happened during the procedure and there is no objective evidence or descriptive conditions to establish the cause of the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 25242195
• Report Number: 3005099803-2026-02005
• Device Sequence Number: 18797475
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: (01)08714729296393(17)260918(10)37485094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/21/2026

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: 09/18/2026
• Device Model Number: M00510880
• Device Catalogue Number: M00510880
• Device Lot Number: 0037485094
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 09/18/2025
• 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