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

Model Number M00510890

Device Problems Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: initial reporter facility name is (b)(6).Block h6: imdrf device code a0406 captures the reportable investigation finding that the sidecar rx was pushed back.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection found the proximal section of the sheath was buckled and detached from the heat shrink.The sidecar rx was observed to be pushed back approximately 9.0 mm which is out of specification.Functional inspection found the basket did not open due to the detachment of the sheath.The reported event was confirmed.Based on all available information, it is most likely that procedural factors encountered could have affected the device leading to the observed failures.Manipulation and technique can lead to buckling and detachment of the sheath, consequently failing the basket to open.Manipulation while advancing the device into the scope and lead to the side car rx push back.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during procedure and the device had no influence on event.A review of the manufacturing documentation for this reveled that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available the device was used per the instructions for the use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, when the basket was about to be opened for stone removal, the sheath was torn from the heat shrink.The device could not be opened and had to be removed from the patient.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.The investigation results revealed the sidecar rx was pushed back; therefore, this is now an mdr reportable event.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: 17246367
• MDR Text Key: 318381885
• Report Number: 3005099803-2023-03440
• 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: 07/03/2023

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: 11/22/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0030583453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 65 KG