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

Model Number M00510890

Device Problems Material Deformation (2976); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable investigation finding of side car rx pushback.Block h10: the returned trapezoid rx was analyzed, and a visual inspection observed the side car rx was pushed back and the rear end is stretched out.Additionally, the basket was found folded.Dimensional testing confirmed the side care rx push back.Functional testing found the basket was difficult to deploy and the tension applied to the handle made the working length retract itself, pushing back the side car rx.The reported event was confirmed.Based on all available information, it is likely that the bent basket was caused by the repeated used.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the common bile duct during an endoscopic biliary stone removal procedure performed on (b)(6) 2023.During the procedure, the trapezoid rx was inserted into the common bile duct in an attempt to perform lithotripsy.However, it was difficult to grasp the stone; therefore, the device was removed from the body and inspected.It was noticed that the tip part and rear end of the basket (sheath side) were twisted, and the wire spacing went uneven.Device was discontinued and a different device was used to complete the procedure.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation finding of side car rx pushback.Please see block h10 for full investigation details.

• Brand Name: TRAPEZOID RX
• Type of Device: 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18187682
• MDR Text Key: 328763131
• Report Number: 3005099803-2023-06332
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2024
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031699376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1