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

Model Number	2747
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: weight: 94.30 kg.
Event or Problem Description
It was reported via facility medwatch report 14797797086-2024-0001 that tip detachment occurred.A 182cm luge guidewire was selected for used.However, during procedure, the tip of the wire broke off into the patient.Surgical intervention was then performed.No patient complications were reported.
Additional Manufacturer Narrative
A4: weight: 94.30 kg.
Event or Problem Description
It was reported via facility medwatch report 14797797086-2024-0001 that tip detachment occurred.A 182cm luge guidewire was selected for used.However, during procedure, the tip of the wire broke off into the patient.Surgical intervention was then performed.No patient complications were reported.It was further reported that the during the procedure, when the physician entering the coronary sinus to implant a pacemaker, the wire was used to prolapse but when the physician was ready to pull out the luge wire, it caught on the lead or the catheter which then created a complete separation of the radiopaque tip from the body of the wire.The physician attempted to snare out the tip of the wire and was unsuccessful.The main body of the wire was removed, and the radiopaque tip of the wire was left in the coronary sinus of the patient.The patient remained stable.

• 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: 18770139
• Report Number: 2124215-2024-07362
• Device Sequence Number: 18091681
• Product Code: DQX
• UDI-Device Identifier: 08714729252320
• UDI-Public: 08714729252320
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: 08/02/2025
• Device Model Number: 2747
• Device Catalogue Number: 2747
• Device Lot Number: 0032147371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White