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

Model Number	M00510870
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the biliary duct during a stone retrieval procedure performed on (b)(6) 2024.During the procedure, the tip of the basket detached before lithotripsy could be performed.A different device was used to complete the procedure.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 tip premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx was used in the biliary duct during a stone retrieval procedure performed on (b)(6) 2024.During the procedure, the tip of the basket detached before lithotripsy could be performed.A different device was used to complete the procedure.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 tip premature deployment.Block h11: the returned trapezoid rx was analyzed, and a visual inspection observed that the basket tip was not returned, and the side car rx was pushback.The reported event was confirmed.Premature deployment of the tip cannot be seen during the product analysis; however, the device returning without the tip is evidence that it could have detached prematurely.The tip can detach prematurely due to the physician technique when grabbing the device from the thumb ring.If the thumb ring is grabbed with too much force, even with the basket closed, it can add stress to the wire causing the tip to detach.It was also observed that the side car was push back.This is most likely due to the technique used during preparation of the device.Manipulation of the thumb ring from the handle when preparing the device to be used can cause the working length to retract and push back the side car rx.Therefore, based on all available information, the most probable conclusion is adverse event related to procedure.

• 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: 19228923
• Report Number: 3005099803-2024-01988
• Device Sequence Number: 17622279
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 08/09/2024

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: 01/07/2025
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0033157258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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