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

Model Number	008631
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
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
An angiographic guide wire was used during a procedure.There was no damage noted to the packaging.There were no issues noted removing the device from the packaging.The device was inspected with no issues.The device was prepped per ifu with no issues.It was reported that the guide wire unraveled inside the calibrated pig guide, the wire fractured while being used and then caused thrombus to form in the wire.The patient is alive with no further injury.
Additional Manufacturer Narrative
One still image was provided showing the distal end of an angiographic wire.On one section of the wire, the coils appear slightly separated/deformed.However, an analysis of the image by the vendor suggests that the coil separation/deformation is due to the safety wire being broken/detached.From the image provided, no portion of the wire appears unraveled.It is unknown whether there is any other damage to the wire.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: 9254486
• Report Number: 1220452-2019-00138
• Device Sequence Number: 2486182
• Product Code: DQX
• UDI-Device Identifier: 00643169857124
• UDI-Public: 00643169857124
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 06/28/2024
• Device Model Number: 008631
• Device Catalogue Number: 008631
• Device Lot Number: GFDT3014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1