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

Model Number	M00510890
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	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a23 captures the reportable event of basket failure to crush stone.Imdrf device code a0401 captures the reportable event of basket wire break.Imdrf device code a150301 captures the reportable event of tip failure to separate.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was used to remove a stone (about 2.5 cm) in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2026.During the procedure, it was reported that they managed to trap the stone inside the basket.However, it would not break during lithotripsy even with the use of an alliance ii multi-purpose handle.The basket wire broke and slipped off, while the basket tip remained intact and stayed within the biliary tract.Based on the photo provided by the complainant, the tip remained in position.The procedure was completed with using a transnasal endoscope.There were no patient complications reported as a result of this event.Following the procedure, the patient is expected to fully recover.

• 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: 25243057
• Report Number: 3005099803-2026-02006
• Device Sequence Number: 16088941
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/18/2026

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: 0038482052
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 01/30/2026
• 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