MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE MAGNET MODERATE SUPPORT J TIP WIRE (0.014 IN X 182 CM) GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	CATALOG # OR MODEL # H7491213001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During implantation of aicd, the luge magnet guidewire became tangled inside the coronary sinus vessel.While maneuvering the wire, the tangled part broke off from the main wire.Fda safety report id# (b)(4).

• Brand Name: LUGE MAGNET MODERATE SUPPORT J TIP WIRE (0.014 IN X 182 CM) GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10762446
• Report Number: MW5097561
• Device Sequence Number: 16422507
• Product Code: DQX
• UDI-Device Identifier: 08714729895886
• UDI-Public: 08714729895886
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: CATALOG # OR MODEL # H7491213001
• Device Catalogue Number: CATALOG # OR MODEL # H74912130
• Device Lot Number: 25358342
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 92