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

Model Number	M00510870
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used during a ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2024.During the procedure, the tip of the basket prematurely detached when attempting to crush a 2cm stone.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of the tip of the basket prematurely detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of the tip of the basket prematurely detached.Block h11: the trapezoid rx was returned for analysis.The trapezoid rx returned without the tip.The side car rx was pushed back and torn resulting in the basket wires being unable to deploy.The investigation finding of side car rx pushed back was likely due to amount of force applied to the thumb ring from the handle when trying to destroy the stone.With excessive force, the working length tends to retract itself, pushing back the side car rx.In addition, the interaction with the guidewire during the procedure and the technique used by the physician, could have caused the side car rx to tear at the beginning of the guide wire channel.Additionally, it was reported that the device basket had the stone inside when the tip was detached.However, this is how the device is intended to work if the stone cannot be crushed.It's most likely that the hardness of the stone didn't allow the basket to destroy it, and the device deployed the tip to release the stone safely.Taking all available information into consideration, the root cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used during a ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2024.During the procedure, the tip of the basket prematurely detached when attempting to crush a 2cm stone.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: TRAPEZOID RX
• Common Device Name: 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: 19853284
• Report Number: 3005099803-2024-03615
• Device Sequence Number: 6556954
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2025
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0033949254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown