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

Model Number	GWR419588
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the guidewire was removed from the packaging, the distal end of the hybridwire separated.The guidewire was not used with the patient.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full guidewire was returned and analyzed, the guidewire was unraveled.The stylet/guidewire was kinked/buckled.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7090729
• Report Number: 1220452-2017-00125
• Device Sequence Number: 1895503
• Product Code: DQX
• UDI-Device Identifier: 00643169452411
• UDI-Public: 00643169452411
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K143316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 01/28/2018
• Device Model Number: GWR419588
• Device Catalogue Number: GWR419588
• Device Lot Number: 0008021694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR