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

Model Number	007447
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
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 in pe 703553375 0.035 x 145cm ptfe guide wires became deformed during several procedures.It was reported that the outer core of the wire separated from the inner core of the wire.There was no impact to the patient and their current status is good.
Additional Manufacturer Narrative
When it was observed that the inner core of the wire was removable, (not intact) it was decided not to risk the patients.The wires were not used in a patient.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ANGIOGRAPHIC GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9620084
• Report Number: 1220452-2020-00010
• Device Sequence Number: 2474666
• Product Code: DQX
• UDI-Device Identifier: 00643169856844
• UDI-Public: 00643169856844
• Combination Product (Y/N): N
• Initial Reporter Country: UG
• PMA/510(K) Number: K082873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 01/28/2024
• Device Model Number: 007447
• Device Catalogue Number: 007447
• Device Lot Number: GFDN0680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1