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

Model Number M00510870

Device Problems Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the tracheobronchial during a stone retrieval procedure performed on (b)(6) 2023.During procedure, the sheath was disconnected with the handle.The procedure was completed with another trapezoid rx.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the trapezoid rx wireguided retrieval basket was used in the tracheobronchial anatomy; however, per the trapezoid rx wireguided retrieval basket instructions for use (ifu), the device is indicated for endoscopic crushing and removal of biliary calculi and the reported anatomy location is not described in the indications for use.Note: this event has been deemed a reportable event based on the investigation finding of handle cannula detached.Please see block h10 for full investigation details.

Manufacturer Narrative

Block d4; h4: the complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection noted the handle cannula was broken and the side car rx was torn.The sheath was in good condition.No other issues were noted.The reported event was not confirmed as the sheath near the handle was returned in good condition.Based on all available information, it is possible that the device was subjected to excessive force during the procedure, which could have resulted in the handle cannula breaking and the torn side car rx.Therefore, the most probable root cause for the issues found during analysis is adverse event related to procedure.However, the reported issue of sheath break was not confirmed during the analysis.Therefore, the root cause for the reported issue is no problem detected.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu) as the trapezoid rx wireguided retrieval basket device was used in the tracheobronchial anatomy; however, per the ifu, the device is indicated for endoscopic crushing and removal of biliary calculi and the reported anatomy location is not described in the indications for use.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.

• 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: 18104297
• MDR Text Key: 327766793
• Report Number: 3005099803-2023-06087
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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