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

Model Number	M00510870
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	11/17/2025
Type of Reportable Event	Serious Injury
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) with stone removal procedure performed on (b)(6) 2025.During the procedure, an alliance ii handle was used in conjunction with the trapezoid rx to attempt stone extraction of a 1.5-2.0 cm stone.During use, the handle broke, and the basket tip failed to separate from the basket.The distal bile duct was subsequently dilated using a 4 mm hurricane balloon in an attempt to remove the basket and stone; however, this attempt was unsuccessful.The patient was scheduled for a follow-up ercp with spyglass/laser lithotripsy on (b)(6) 2025, to fragment the stone and facilitate basket removal.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf a0401 captures the reportable event of handle break.Imdrf a23 captures the reportable event of basket failure to crush stone.Imdrf a150301 captures the reportable event of tip failure to separate.Imdrf f2301 captures the reportable event of additional device required to remove the basket and the stone.Imdrf f2202 captures the additional endoscopic procedure of ercp with spyglass/laser.

• 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: 23874664
• Report Number: 3005099803-2025-06841
• Device Sequence Number: 18752561
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: (01)08714729296386(17)260825(10)37292491
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2026
• Device Model Number: M00510870
• Device Catalogue Number: M00510870
• Device Lot Number: 0037292491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/23/2025
• Date Device Manufactured: 08/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown