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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that distal tip detachment occurred.A 182cm luge guidewire was selected for use.However, during the procedure, a 3 cm tip of the guidewire came off into the coronary sinus branch.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that distal tip detachment occurred.A 182cm luge guidewire was selected for use.However, during the procedure, a 3 cm tip of the guidewire came off into the coronary sinus branch.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: the device was returned for analysis.Visual inspection revealed that the body of the guidewire was kinked.The observed kink of the body was measured, and the distance of the kink is 1-51.0 in.Microscopic inspection revealed that the distal tip was bent, and 5.1 in of the distal tip was detached and did not return for analysis.Dimensional inspection included measurement of the total length of the returned guidewire.The length of the guidewire was within normal limits, even though that a section of the distal tip was detached and did not return for analysis.

• 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: 19264354
• Report Number: 2124215-2024-27703
• Device Sequence Number: 6492865
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Expiration Date: 10/19/2024
• Device Model Number: 2747
• Device Catalogue Number: 2747
• Device Lot Number: 0030387125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown