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

Model Number M00510890

Device Problems Break (1069); Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921); Material Deformation (2976)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device problem code a0406 captures 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 the sheath was buckled and detached at the proximal section.Additionally, the side car rx was pushed back 3.5 mm, which is out of specification.A functional test noted that the basket was able to open without problems at the first attempt.The reported event of basket failed to open was not confirmed.Based on all available information, the sheath detachment and buckling indicates possible difficulty in trying to open the basket, which may cause excess tension on the working channel.This could result in separating the sheath and could have caused the side car rx push back.Therefore, the most probable root cause of the issues found during analysis is adverse event related to procedure.However, the functional test showed that it is possible to open the basket.Perhaps the manipulation, technique used, or patient's anatomical conditions could have contributed to this event.Therefore, the most probable root cause for the reported event is "no problem detected".

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile during a choledochotomy procedure performed on (b)(6) 2023.During the procedure, the basket failed to open.Another trapezoid rx basket was used to complete the procedure.There were no patient's complications as a result of this event.The patient's condition at the conclusion of the procedure is reported to be stable.Note: this event has been deemed a reportable event based on the investigation finding of sidecar push back.Please see block h10 for full investigation details.

• 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: 17932948
• MDR Text Key: 326322187
• Report Number: 3005099803-2023-05431
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/13/2023

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 Expiration Date: 02/27/2024
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031127163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG