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

Model Number	MDT-GUIDEWIRE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during implant procedure the guide wire of introducer sheath was damaged, the metal thread was ¿frayed¿.The guide wire was replaced with a different product.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.

• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6469261
• Report Number: 2182208-2017-00584
• Device Sequence Number: 16291322
• Product Code: DQX
• UDI-Device Identifier: 00681490143349
• UDI-Public: 00681490143349
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2017

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 Model Number: MDT-GUIDEWIRE
• Device Catalogue Number: MDT-GUIDEWIRE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR