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

Model Number	M00510870
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	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.E1: initial reporter city is (b)(6).H6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a23 captures the reportable event of basket failure 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 an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, an alliance handle was used with the trapezoid rx.However, the basket was unable to crush the stone, and the tip of the basket failed to detach.The catheter was cut, and a sohendra lithotripter was used to detach the tip and complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: initial reporter city is (b)(6).Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a23 captures the reportable event of basket failure to crush stone.Block h11: the returned trapezoid rx was analyzed, and product evaluation revealed that the handle cannula was bent and detached from the handle.The working length was observed to be bent, and the wire between the handle cannula and basket wire was kinked.The basket tip was found detached and was not returned.With all the available information, boston scientific concludes that the reported event of basket failure to crush stone was confirmed.However, the reported event of tip failure to separate was not confirmed.Procedural factors, such as device handling and the technique used by the physician (force applied), most likely caused the observed damage.Additionally, the handle cannula was found detached (likely detached by the customer or due to excessive force/pressure applied), and the basket tip was missing.The customer reported that the catheter was cut, and a sohendra lithotripter was used to complete the procedure.It's possible that the customer separated the handle cannula from the handle or how the device was being used alongside with the alliance handle, if there was more pressure than the device could handle, this could have made the handle cannula to detach, and subsequently used another device to remove the tip due to difficulty crushing the stone and because the tip was difficult to separate during the procedure.The events of "basket failure to crush stone", "handle cannula detached/separated", "handle cannula bent/kinked", "tip detached/separated", "working length bent/kinked" and "wire bent/kinked" will be cataloged as an adverse event related to procedure, since the adverse events occurred during the procedure and the device did not contribute to it.Furthermore, the reported event of "tip failure to separate" cannot be confirmed because it happened during the procedure and there was no objective evidence or descriptive conditions to confirm the reported event.For this reason, will be classified as "cause not established".All compiled information on this investigation determines that the most probable cause is "adverse event related to procedure".
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 an unknown date.During the procedure, an alliance handle was used with the trapezoid rx.However, the basket was unable to crush the stone, and the tip of the basket failed to detached.The catheter was cut, and a sohendra lithotripter was used to detach the tip and complete the procedure.There were no patient complications as a result of this event.

• 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: 23190937
• Report Number: 3005099803-2025-04934
• Device Sequence Number: 15739960
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: (01)08714729296386(17)260401(10)36199802
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/19/2025

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: 04/01/2026
• Device Model Number: M00510870
• Device Catalogue Number: M00510870
• Device Lot Number: 0036199802
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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 Sex: Unknown