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

Model Number	M00510870
Health Effect - Clinical Codes	Bradycardia (1751); Foreign Body In Patient (2687)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the case, a wire guided retrieval basket was deployed, the gallstone was captured in the basket and was attempted to be crushed with the product.When doing so, there is a failsafe, where the tip of the basket pops off if the stone is unable to be crushed.When this tip comes off, the basket can then slip off the stone and be removed.In this case the tip did not detach, which caused the basket to be stuck on the stone.The basket with the stone was attempted to be removed from the patient; however, it was too large and whenever the wire was pulled the patient began to become bradycardic, due to this the basket and stone was left in the patient with the guidewire cut at the distal end.[redacted] recommendation was to transfer the patient to [redacted] where they have eus, spyglass and lithotripsy.Patient was emergently transferred to [redacted] hospital.We do have spyglass here but [redacted] nor his partners are trained in use, and [redacted] felt eus may be needed, a service we do not have, nor (b)(6).

• Brand Name: TRAPEZOID RX
• Common Device Name: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 20245806
• Report Number: 20245806
• Device Sequence Number: 7282705
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: (01)08714729296386
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/05/2024
• Report Date (Section F): 06/05/2024

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 Model Number: M00510870
• Device Catalogue Number: M00510870
• Device Lot Number: 34049728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 64 KG
• Date Report Sent to FDA: 06/05/2024