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

Catalog Number	007044
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the wire is exhibiting a short piece of wire sticking out approximately 2.5 cm from the wire distal tip, the wire is sticking out between the coils.A slight pull was done to determine if the piece of wire could be removed, but the piece of wire remained stuck.No other damage noted to the wire.It was confirmed that the safety wire was protruding from the outer spring.There were signs of necking at the location of the wire break, indicating a ductile failure (compared to brittle).The spring was stretched to assess the safety wire weld.It was confirmed that the weld did not fail.The wire broke approximately 1cm from the distal weld.Additionally, it was later confirmed using peroxide that approximately 50cm of the wire had traces of blood.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
There was no damage noted to the angio graphic wire packaging.The wire was removed from packaging per ifu.On inspection the wire was noted to be damaged.The wire tip was not formed by the physician.The wire was not prepped.Issue was noted prior to use.

• 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: 8339383
• Report Number: 1220452-2019-00014
• Device Sequence Number: 19396602
• Product Code: DQX
• UDI-Device Identifier: 00643169856738
• UDI-Public: 00643169856738
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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: 02/28/2023
• Device Catalogue Number: 007044
• Device Lot Number: GFCQ1548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1