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

Model Number	GWR419688
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The guidewire was returned and analyzed.Analysis indicated there was an issue with the shape of the guidewire.The guidewire was unraveled.There was blood on the guidewire.Visual analysis of the guidewire indicated damage during use.The analyst noted the guidewire was returned with the distal end deformed/bent, and wire unraveled at 1.8 from the distal tip.Dried blood is observed at 0.5 cm from the guidewire distal tip.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that prior to use the guidewire appearance was not as expected and was noted to be bent.The guidewire was not used.There was no patient involvement.The guidewire was returned to the manufacturer, analyzed and tested out of specification.

• 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: 15680098
• Report Number: 1220452-2022-00080
• Device Sequence Number: 15068650
• Product Code: DQX
• UDI-Device Identifier: 00643169452398
• UDI-Public: 00643169452398
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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: 02/24/2024
• Device Model Number: GWR419688
• Device Catalogue Number: GWR419688
• Device Lot Number: 0011121541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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