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

Model Number M00510870

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

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

Event Date 12/19/2023

Event Type  malfunction  

Event 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 (b)(6) 2023.During the procedure, the basket was unable to open.There were no patient complications as a result of this event and the procedure was completed with another trapezoid basket.Note: this event has been deemed a reportable event based on the investigation finding of sidecar rx push back.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0406 is being used to capture the reportable investigation result of side car rx push back.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection observed that that the side car rx was pushed back and buckled.A dimensional test confirmed that the side car rx was pushed approximately 4 mm, which is out of specification.A functional test performed, and the basket was able to open accordingly.The reported event of basket failure to open was not confirmed.Based on available information, the side car rx push back and buckled accordion could have occurred due to excessive manipulation attempting to open the stuck basket.The technique used, or patient's anatomical condition could have contributed to this event.Therefore, the most probable root cause for the problems found during analysis is adverse events related to procedure.However, the reported event of basket failure to open was not confirmed during analysis as the basket was able to open properly.Therefore, the root cause for the reported problem is no problem detected.

• 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: 18885969
• MDR Text Key: 337458566
• Report Number: 3005099803-2024-00886
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0032106229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2023
• 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