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

Catalog Number	007447
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
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
The angio graphic j wire was initially observed and utilized in the left proximal popliteal artery without issue.The wire was prepped for use as per the ifu.The target lesion had plaque present, little calcification, little tortuosity and 40-50% stenosis.No resistance was felt advancing the wire.Upon the 4th use and removal of the j wire from the catheter, it was noticed the wire seemed longer than earlier usage and upon further observation, a smaller transition in diameter of the wire was also noticed at the distal end.Fluoroscopy was utilized by the physician to confirm that the entire wire was removed.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis: as received the wire is bent/ kinked in three locations at the distal end of the wire.The movable core of the wire is withdrawn approximately 30 cm.The movable core could no longer be moved due to the kinks in the distal end of the wire.No notable defect other than physical damage was noted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional device analysis: no notable defect other than physical damage was noted.The device was found to conform to the end item drawing.The guide wire appeared longer because the moveable core wire had been partially removed from the spring during retraction.The outer diameter appeared to be smaller, because the diameter of the core wire is smaller than the diameter of the spring.No discrepancies were found.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: 7859542
• Report Number: 1220452-2018-00107
• Device Sequence Number: 11250398
• Product Code: DQX
• UDI-Device Identifier: 00643169856844
• UDI-Public: 00643169856844
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 11/21/2018

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: 02/28/2023
• Device Catalogue Number: 007447
• Device Lot Number: GFCP3703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 11/20/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 11/13/2018; 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 82