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

Model Number M00510890

Device Problems Use of Device Problem (1670); Separation Failure (2547); Difficult to Open or Close (2921)

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

Event Date 01/15/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during endoscopic cholangiopancreatography (ercp) with a stone retrieval procedure performed on (b)(6)2024.During the procedure, the 3 cm trapezoid rx basket was used to trap a 1 cm stone.An alliance handle was used to crush the stone, as the basket could not crush the stone manually.There was stone debris that remained in the basket, and the tip would not detach to release the stone.Fortunately, the stone fragment got loose from the basket.A non-bsc device was used to complete the procedure.There were no patient complications as a result of this event.Note: it was reported that the trapezoid rx 3cm was used to crush a 1cm diameter stone; however, per the trapezoid rx wireguided retrieval basket instructions for use (ifu), the 3 cm basket is designed for crushing calculus larger than 1.5 cm (15 mm) in diameter.

Manufacturer Narrative

Imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a051104 captures the reportable event of basket failure to crush stone.

• 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: 18650581
• MDR Text Key: 334739140
• Report Number: 3005099803-2024-00308
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 0032653794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• 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