MAUDE Adverse Event Report: ABBOTT MEDICAL GUIDERIGHT GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	404560
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the pulsed field ablation (pfa) procedure for atrial fibrillation, a guidewire fractured.When a guidewire was placed in the left atrium the physician felt something abnormal while manipulating the wire so it was removed from the patient and it was observed to be fractured near the base of the j-curve.The guidewire was replaced with the same model and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One guideright guidewire was received for evaluation.Many bends were noted along the guidewire.The receiving inspection was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bends remains unknown.

• Brand Name: GUIDERIGHT GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23008923
• Report Number: 3005334138-2025-00538
• Device Sequence Number: 10502416
• Product Code: DQX
• UDI-Device Identifier: 05414734013178
• UDI-Public: 05414734013178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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 Model Number: 404560
• Device Catalogue Number: 404560
• Device Lot Number: 9945029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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