MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Trapezoid RX; lithotriptor, biliary mechanical

Model Number	M00510880
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
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, a trapezoid rx was used with an alliance ii handle to attempt to crush a 10mm biliary stone.However, the handle cannula broke.The basket was manually removed from the biliary duct but with difficulty.Another trapezoid rx was used to complete the procedure.No patient complications were reported; however, the procedure took longer than anticipated due to the equipment fault.The patient's condition following procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of handle cannula break.Imdrf device code a150207 captures the reportable event of device difficult to remove.Imdfr device code a23 captures the reportable event of basket failure to crush stone.Block h11: the complaint device was not returned; therefore, product analysis could not be performed.For this reason and due to lack of evidence the reported event cannot be confirmed.The device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.A similar complaint review was completed.There were no emerging trends identified that warrant further action.A risk review was completed and confirmed that the events of "handle cannula break, device difficult to remove, and basket failure to crush stone" were 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 information provided, the most probable cause of the reported issues "handle cannula break, device difficult to remove, and basket failure to crush stone" cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.Also, for the events additional device required and prolonged episode of care, it happened during the procedure, and the most probable cause of these reported issues cannot be established due to lack of evidence.For this reason, the event will be classified as cause not established.All compiled information on this investigation determines that the most probable cause is 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 ; +1(914)571-6918
• MDR Report Key: 50850698
• Report Number: 3005099803-2026-03900
• Device Sequence Number: 10025690
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: (01)08714729296393(17)270326(10)38936771
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 0038936771
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 03/26/2026
• 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