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

Model Number M00510870

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the ductus hepaticus (hepatic duct) during a lithotripsy procedure performed on (b)(6) 2024.During the procedure, the basket was used in an attempt to remove a bile stone.While trying to crush the stone using the lithotripsy handle, the whole basket fell off, and it was found in the duodenum using fluoroscopy.It is currently unknown if the basket was removed during the procedure or if it was planned to be removed.A different device was used to complete the procedure.There were no patient complications as a result of the event.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of basket detachment.

• 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: 18924940
• MDR Text Key: 337917585
• Report Number: 3005099803-2024-00989
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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