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

Model Number	M00510890
Medical Device Problem Codes	Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of side car rx torn material.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the gallbladder for stone removal during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, it was reported that the side car rx channel was damaged, and the guidewire could not cross smoothly.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the gallbladder for stone removal during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6)2026.During the procedure, it was reported that the side car rx channel was damaged, and the guidewire could not cross smoothly.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of side car rx torn material.Block h11: investigation results: the complaint device was not returned therefore, product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.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 "side car rx torn material" was defined in the risk documentation.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 "side car rx torn material" and "device difficult to advance guidewire" 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.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: 25740372
• Report Number: 3005099803-2026-02707
• Device Sequence Number: 13375491
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409(17)261205(10)38117672
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 08/12/2026

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: M00510890
• Device Catalogue Number: M00510890
• Device Lot Number: 0038117672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 12/05/2025
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 182 LB