MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE; WIRE, GUIDE, CATHETER

Model Number	2747
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a guidewire fracture occurred and a portion of the device was left in the patient.A 182cm luge guidewire was advanced.However, a small portion of the wire broke off and the rest of the wire came back into the non-bsc support catheter.The physician decided to proceed and complete procedure with the device.There were no patient complications nor injuries reported and the patient remained stable.The patient was discharged the following day.
Event or Problem Description
It was reported that a guidewire fracture occurred and a portion of the device was left in the patient.A 182cm luge guidewire was advanced.However, a small portion of the wire broke off and the rest of the wire came back into the non-bsc support catheter.The physician decided to proceed and complete procedure with the device.There were no patient complications nor injuries reported and the patient remained stable.The patient was discharged the following day.
Event or Problem Description
It was reported that a guidewire fracture occurred and a portion of the device was left in the patient via maude mw5097561.A 182cm luge guidewire was advanced.However, a small portion of the wire broke off and the rest of the wire came back into the non-bsc support catheter.The physician decided to proceed and complete procedure with the device.There were no patient complications nor injuries reported and the patient remained stable.The patient was discharged the following day.It was further reported that the luge magnet guidewire became entangled inside the coronary sinus vessel.While maneuvering the wire, the tangled part broke off from the main wire.

• Brand Name: LUGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10712074
• Report Number: 2134265-2020-14477
• Device Sequence Number: 19653717
• Product Code: DQX
• UDI-Device Identifier: 08714729877097
• UDI-Public: 08714729877097
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: 2747
• Device Catalogue Number: 2747
• Device Lot Number: 0025358342
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 11/23/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/03/2020; 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: TRAILBLAZER; CATHETER: TRAILBLAZER; CATHETER: TRAILBLAZER; CATHETER: TRAILBLAZER
• Outcome Attributed to Adverse Event: Other