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

Model Number	2747
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via user facility medwatch (b)(4) that guidewire fracture occurred.During the intracardiac defibrillator insertion, a 182cm (5pk) luge guidewire intended to locate the coronary sinus broke off inside the patient, leaving approximately 3cm of the fragment irretrievable.The luge guidewire was intact when removed from its packaging, but the end broke off within the patient during the procedure.No further information was able to be obtained.
Additional Manufacturer Narrative
Correction to h10 to include referenced related emdr number from b5.
Event or Problem Description
It was reported via user facility medwatch (b)(4) that guidewire fracture occurred.During the intracardiac defibrillator insertion, a 182cm (5pk) luge guidewire intended to locate the coronary sinus broke off inside the patient, leaving approximately 3cm of the fragment irretrievable.The luge guidewire was intact when removed from its packaging, but the end broke off within the patient during the procedure.No further information was able to be obtained.

• Brand Name: LUGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19760881
• Report Number: 2124215-2024-41722
• Device Sequence Number: 8778113
• Product Code: DQX
• UDI-Device Identifier: 08714729252320
• UDI-Public: 08714729252320
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 10/19/2024
• Device Model Number: 2747
• Device Catalogue Number: 2747
• Device Lot Number: 0030387125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 07/22/2024
• Date Device Manufactured: 10/20/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: White