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

Model Number	2746
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a guidewire fracture occurred.Patient underwent percutaneous coronary intervention.The target lesion was located in the distal left anterior descending artery.A 182 cm luge guidewire was selected for use.However, during removal, the tip of the wire was broken and could not be retrieved.The procedure was completed.
Event or Problem Description
It was reported that a guidewire fracture occurred.Patient underwent percutaneous coronary intervention.The target lesion was located in the distal left anterior descending (lad) artery.A 182 cm luge guidewire was selected for use.However, during removal, the tip of the wire broke off in the distal lad and could not be retrieved.The procedure was completed.
Additional Manufacturer Narrative
Corrected: h6 device codes: a040101 fracture corrected to a0501 detachment of device or device component.

• 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: 19032661
• Report Number: 2124215-2024-20226
• Device Sequence Number: 6992180
• Product Code: DQX
• UDI-Device Identifier: 08714729169963
• UDI-Public: 08714729169963
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 01/15/2026
• Device Model Number: 2746
• Device Catalogue Number: 2746
• Device Lot Number: 0033214000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female