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

Model Number M00510880

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

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

Event Date 09/13/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used during a procedure performed on (b)(6) 2023.During preparation, the handle was closed.It appears that during the attempt to retract the basket, the tip was not fully retracted into the sheath.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.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 e1: initial reporter fax: (b)(6).Block h6: imdrf device code a0406 captures the reportable investigation results of side car rx push back.Block h10: the returned trapezoid rx device was analyzed, and a visual evaluation observed that the side car rx was pushed back.A dimensional test was performed and confirmed that the side car was pushed back 2.5 mm, which is out of specification.A functional test noted that the basket was able to open and close properly.The reported event of basket failure to close was not confirmed.Based on the available information, the basket did not have any problems opening and closing.However, the side car rx was pushed back which often triggers other problems during use.This problem could have occurred due to excessive manipulation when trying to operate the basket, technique used, or the patient's anatomical conditions.Therefore, the most probable root cause for the issue found during analysis is "adverse event related to procedure".

• 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: 18252039
• MDR Text Key: 330246936
• Report Number: 3005099803-2023-06399
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0032009965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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