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

Model Number	M00510880
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the handle could not be opened, and it was found the handle cannula was "lifted up".The procedure was completed with another of same device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Block h6: device code a040609 captures the reportable event of handle cannula bent.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Block h6: device code a040609 captures the reportable event of handle cannula bent.Block h2: correction to block h6.Imdrf device code a051104 has been added to capture the event "the handle could not be opened." block b5 has been updated based on additional information received on august 11, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the handle could not be opened, and it was found the handle cannula was "lifted up".The procedure was completed with another of same device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on 11aug2025*** an alliance handle was used with the trapezoid rx.The stone was about 2 mm.The basket could not be open and the handle was found bent.There was no stone inside the basket when it failed to open.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the handle could not be opened, and it was found the handle cannula was "lifted up".The procedure was completed with another of same device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on 11aug2025.An alliance handle was used with the trapezoid rx.The stone was about 2 mm.The basket could not be open and the handle was found bent.There was no stone inside the basket when it failed to open.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Block h6: device code a040609 captures the reportable event of handle cannula bent.Block h11: the returned trapezoid rx was analyzed, and the device was observed with the handle cannula kinked.The sheath was observed damaged under microscope inspection.Also, during functional test it was not possible to open/deploy the device basket.The reported event of handle cannula kinked was confirmed.Based on all available information, it is possible that handle cannula kink is due to the same force that was applied to actuating the handle.This force, or the technique used, may have made it impossible to open the basket during the procedure and could have caused the sheath to tear or become damaged under the pressure.Therefore, the most probable root cause is "adverse event related to procedure".

• 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: 22740264
• Report Number: 3005099803-2025-03705
• Device Sequence Number: 13037556
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: (01)08714729296393(17)260115(10)35633454
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2025

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 Expiration Date: 01/15/2026
• Device Model Number: M00510880
• Device Catalogue Number: M00510880
• Device Lot Number: 0035633454
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 09/19/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/03/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 73 KG