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

Model Number	GWR419588
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed.The analysis indicated that the guidewire was unraveled.There was an issue with the curvature/shape of the stylet/guidewire.There was blood on the stylet/guidewire.Visual analysis of the guidewire indicated damage during use.The analyst noted the guidewire was returned without the packaging.The distal tip of the guidewire is unraveled at 106 cm.The distal end of the guidewire is curled.There is blood on the guidewire at 106 cm.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 tip of the guidewire was noted to be twisted/curled and the physician was unable to insert the guidewire into the lead.The guidewire was not used.Subsequently, the guidewire was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN HYBRID GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 11578452
• Report Number: 1220452-2021-00011
• Device Sequence Number: 4266266
• 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: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 08/09/2022
• Device Model Number: GWR419588
• Device Catalogue Number: GWR419588
• Device Lot Number: 0010348227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR