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

Model Number	M00510890
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation finding of handle cannula detached/separated.Block h11: the returned trapezoid rx was analyzed, and a product analysis found the sidecar rx was pushed back 4mm, the working length was bent, and the handle cannula detached.It was not possible to close the basket due to the damage found in the device.Under microscope inspection, both screw dimples were observed in the cannula.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.Based on all available information, after product analysis, the handle cannula was found detached from the handle.Both screw dimples were observed on the cannula, but not both had the required depth to keep the cannula attached to the handle, resulting in an inability to close the basket.On the other hand, the side car rx was pushed back 4mm.It is most likely due to the excess 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.Also, the working length was found bent, it is possible that the device manipulation during the procedure or the forced applied could have resulted in the damage observed in the device.All compiled information on this investigation determines that the most probable cause is "quality control deficiency".
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 basket failed to close after being opened inside the patient.The procedure was completed with another same device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of handle cannula detached/separated.Please see block h11 for full investigation details.

• 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: 25385147
• Report Number: 3005099803-2026-02287
• Device Sequence Number: 21445103
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409(17)260820(10)37256641
• 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
• Report Date (Section B): 06/03/2026

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: 08/20/2026
• Device Model Number: M00510890
• Device Catalogue Number: M00510890
• Device Lot Number: 0037256641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• 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