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)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary duct on an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the basket was unable to open inside the patient.There was not a stone inside the basket when it failed to open.Another trapezoid rx was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.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 address 1: (b)(6).Block h6: imdrf device problem code a0406 captures the reportable investigation finding of side car rx push back.The returned trapezoid rx was analyzed, and a visual inspection observed that the sheath was buckled and detached at the proximal section and the side car rx was pushed back.A functional test was performed, and the basket could not open due to the coil being detached.The reported event was confirmed.The detached coil and the damage to the sheath indicate a possible elongation of the coil when trying to open the basket.Based on all the information available, excess force applied in conjunction with the patient's anatomical condition could have contributed to the 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: 17933688
• MDR Text Key: 325711528
• Report Number: 3005099803-2023-05493
• 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

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029889917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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: 60 YR
• Patient Weight: 50 KG