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

Model Number	M00510860
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
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 pancreatic duct during endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.During the procedure, the physician captured the stone using a 1.5 cm basket.However, the technician was unable to fracture the stone manually, so they attached the alliance inflation handle.A popping sound was heard, and it was initially thought that the tip had broken off.Upon further inspection, it was discovered that the handle had separated from the wire, and the basket remained in the pancreatic duct around the stone.The physician attempted to pull the wires to retrieve the basket from the duct.They then decided to dilate the duct using an 8 mm hurricane balloon.After two inflations, the physician was able to extract the basket from the duct.The scope was removed from the patient with the basket still inside.The procedure was completed using a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a23 captures the reportable event of failure to crush stone.Imdrf device code a0401 captures the reportable event of handle break.Imdrf impact code f2301captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the pancreatic duct during endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2025.During the procedure, the physician captured the stone using a 1.5 cm basket.However, the technician was unable to fracture the stone manually, so they attached the alliance inflation handle.A popping sound was heard, and it was initially thought that the tip had broken off.Upon further inspection, it was discovered that the handle had separated from the wire, and the basket remained in the pancreatic duct around the stone.The physician attempted to pull the wires to retrieve the basket from the duct.They then decided to dilate the duct using an 8 mm hurricane balloon.After two inflations, the physician was able to extract the basket from the duct.The scope was removed from the patient with the basket still inside.The procedure was completed using a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a23 captures the reportable event of failure to crush stone imdrf device code a0401 captures the reportable event of handle break.Imdrf impact code f2301captures the reportable event of additional device required.Block h11: investigation results: the trapezoid rx was returned for analysis.A media review was conducted, and endoscopic images and an x-ray demonstrated the device positioned inside the patient.The basket and basket wires were observed outside the patient and detached from the device.Visual inspection of the returned device identified the side car rx pushed back approximately 2 mm.The handle was not observed broken.The wire was observed broken and kinked.A destructive analysis was performed, and the remaining portion of the wire was observed broken but still attached to the handle cannula.Based on the available information and the investigation findings, the damage observed is most likely associated with the forces applied during use in conjunction with the observed wire failure.The side car rx pushback is most likely due to force applied to the thumb ring when attempting to crush the stone, resulting in retraction of the working length and subsequent displacement of the side car rx.Considering the broken wire condition identified during analysis, the review and assessment of all available information indicates that the most probable cause of the reported event is cause traced to component failure.

• 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: 23190455
• Report Number: 3005099803-2025-04642
• Device Sequence Number: 15971241
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: (01)08714729296379(17)260117(10)35653949
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 01/05/2026

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: 01/17/2026
• Device Model Number: M00510860
• Device Catalogue Number: M00510860
• Device Lot Number: 0035653949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White