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	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of the tip premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used during a endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2024.During the procedure, the tip of the basket fell off during stone removal.The procedure was completed with another trapezoid rx device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used during a endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2024.During the procedure, the tip of the basket fell off during stone removal.The procedure was completed with another trapezoid rx device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
H6: imdrf device code a150103 captures the reportable event of the tip premature deployment.H11: investigation results: the returned trapezoid rx was received for analysis.Visual examination revealed that the guide side care rx was push back 2 mm, the tip of the basket was detached and did not return.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.Additionally, it was reported that the tip fell off during stone removal.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.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• 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: 20145667
• Report Number: 3005099803-2024-04272
• Device Sequence Number: 4248401
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 07/19/2024
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0032054067
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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 Age: 52 YR
• Patient Sex: Female
• Patient Weight: 60 KG