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); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx was used in the intrahepatic bile duct during an intrahepatic bile duct lithotomy procedure performed on (b)(6) 2023.During the procedure, the outer sheath of the device was found damaged when it was taken out and operated in the patient.A photograph of the device was provided by the customer, and it was observed that the sheath was torn at the proximal section.Another trapezoid rx 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 side car rx push back.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable investigation finding of side car rx push back.Block h10: the returned trapezoid rx was analyzed, and a visual inspection found that the side car rx was pushed back.Additionally, the sheath was buckled, torn and detached.A photo submitted also noted the sheath was detached.The reported event was confirmed.Based on all available information, the excessive force used when resistance was encountered might have resulted in damaging some of the components on the device such as the side car rx and outer sheath.These problems could have occurred due to excessive manipulation when operating the basket.Perhaps the technique used, or the patient's anatomical conditions could have contributed to this event.Therefore, the most probable root cause 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: 18989051
• MDR Text Key: 338746298
• Report Number: 3005099803-2024-01137
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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: 0032648808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• 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 Sex: Female
• Patient Weight: 60 KG