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

Model Number M00510890

Device Problems Difficult to Open or Close (2921); Material Deformation (2976)

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

Event Date 10/15/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Initial reporter address 1: (b)(6).Block h6: imdrf device problem code a0406 captures the reportable investigation finding of side car rx push back.Block h10: the returned trapezoid rx lithotripter basket was received for analysis, and a visual and dimensional inspection observed that the side car rx had been pushed back.Additionally, media inspection of the photo provided by the customer showed the basket not fully opened.A functional test was performed, and the basket opened as expected.The reported event of failure to open was not confirmed; however, device analysis found that the side car rx was pushed back.There was evidence that the basket was attempted to be opened since the side car rx is pushed back; however, the basket opened without any problems during testing.The side car rx push back could have been generated from excessive force applied during attempts to open the basket, leading to stress on the device.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 lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, a trapezoid basket in an attempt to crush a 10mm stone, however the basket had an opening diameter of less than 3 cm; therefore, it was difficult to fully open and capture the stone within the bile duct.The procedure was completed with another trapezoid rx.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the side car rx was pushed back.

• 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: 18477915
• MDR Text Key: 332987530
• Report Number: 3005099803-2023-07061
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031836205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2023
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 77 KG