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

Model Number	M00510860
Medical Device Problem Codes	Use of Device Problem (1670); Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf impact code a150301 captures the reportable event of tip failure to separate.Imdrf impact code a23 captures the reportable event of basket failed to crush stone.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during a fiber choledochoscopy procedure on (b)(6) 2025.During the procedure, the common bile duct stone couldn't be crushed, and the basket tip couldn't be disengaged.The procedure was completed using another trapezoid rx.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h2: additional information block d4 (lot number) and block e1 have been updated based on the additional information received.Block h6: imdrf impact code a150301 captures the reportable event of tip failure to separate imdrf impact code a23 captures the reportable event of basket failed to crush stone.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during a fiber choledochoscopy procedure on (b)(6) 2025.During the procedure, the common bile duct stune couldn't be crushed, and the basket tip couldn't be disengaged.The procedure was completed using another trapezoid rx.There were no reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during a fiber choledochoscopy procedure on (b)(6) 2025.During the procedure, the common bile duct stune couldn't be crushed, and the basket tip couldn't be disengaged.The procedure was completed using another trapezoid rx.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code a150301 captures the reportable event of tip failure to separate imdrf impact code a23 captures the reportable event of basket failed to crush stone.Block h11: a trapezoid rx was received for analysis.The device returned disassembled, only the pull wire was returned.Visual examination of the returned device found the pull wire had evidence that it was previously attached to the handle and was also kinked.The basket wires were kinked.The reported event basket failure to crush stone was not confirmed, however, the reported event tip failure to separate can be confirmed.Based on the available information, the device could have also failed to crush the stone due to the damages seen in the device.It is most likely that the interaction between the stone and the basket ended up getting the basket wires kinked.Therefore, a review and analysis of all available information indicated 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21918343
• Report Number: 3005099803-2025-01752
• Device Sequence Number: 8669468
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: (01)08714729296379(17)250823(10)34700334
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2025

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: 08/23/2025
• Device Model Number: M00510860
• Device Catalogue Number: M00510860
• Device Lot Number: 0034700334
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 06/12/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/20/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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: 76 YR
• Patient Sex: Male