MAUDE Adverse Event Report: MEDTRONIC, INC ATTAIN HYBRID GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GWR419588
Medical Device Problem Codes	Material Fragmentation (1261); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure, the hybrid guidewire that was inserted in the lead had formed a knot and was likely stuck in a distal capillary of the vessel.While the physician attempted to remove the guidewire, it became frayed.A portion of the guidewire was remove, but a piece of the soft part remained stick in the vessel.A replacement guidewire was used to finish the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN HYBRID GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13667707
• Report Number: 1220452-2022-00020
• Device Sequence Number: 4756355
• Product Code: DQX
• UDI-Device Identifier: 00643169452411
• UDI-Public: 00643169452411
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: 09/08/2023
• Device Model Number: GWR419588
• Device Catalogue Number: GWR419588
• Device Lot Number: 0010859016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/04/2022
• Date Device Manufactured: 09/20/2021
• 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