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

Model Number M00510890

Device Problems Leak/Splash (1354); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the investigation result of side car rx pushed back.Block h10: investigation results: one trapezoid rx lithotripter basket was received for analysis, and a visual inspection observed that the device had the side car rx pushed back and torn.A functional test was performed by passing water through the device from the injection port in the handle and no leaks were found.The reported event was not confirmed; however, the side car rx was pushed back and torn.This could have been generated due to the technique used by the physician when passing the device through the endoscope or when pulling the handle to open the basket.Excessive stress on the working length while attempting to open the basket can lead to damage in the side car rx.Taking all available information into consideration, the root cause of the reported clinical observation is no problem detected.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023, for choledochotomy treatment.During the procedure, when attempting to inflate the contrast through the rx exit into the bile duct, it was discovered that inflation was unsuccessful when using the basket.The procedure was completed with another trapezoid rx.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the side car rx was pushed back.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: 18363927
• MDR Text Key: 330990492
• Report Number: 3005099803-2023-06761
• 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,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 0031605843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 66 KG