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

Model Number	GWR419588
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary the guidewire was returned and analyzed.The guidewire was unraveled.The stylet/guidewire was analyzed.The stylet/guidewire was broken.The stylet/guidewire was damaged.Visual analysis of the guidewire indicated damage during use.The analyst noted the guidewire was returned in two segments with the lead.The guidewire distal end was unraveled and fractured.There was tissue on the distal end of the guidewire.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the implant procedure, the guidewire broke off inside the left ventricular (lv) lead.The lv lead was removed and the guidewire was successfully removed from the distal lead tip.A replacement lead was successfully implanted.It was further reported that the guidewire was returned to the manufacturer after use with no reason for the return.The guidewire was analyzed and tested out of specification.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 19300865
• Report Number: 1220452-2024-00030
• Device Sequence Number: 12483361
• Product Code: DQX
• UDI-Device Identifier: 00643169452411
• UDI-Public: 00643169452411
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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
• Device Expiration Date: 09/25/2025
• Device Model Number: GWR419588
• Device Catalogue Number: GWR419588
• Device Lot Number: 0011980960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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