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

Model Number	007042
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with coronary artery disease having a heart catheterization.During the procedure, the j wire stuck in the loop.Ho known harm to patient.

• Brand Name: ANGIOGRAPHIC GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy.; minneapolis MN 55432
• MDR Report Key: 10331827
• Report Number: 10331827
• Device Sequence Number: 17049750
• Product Code: DQX
• UDI-Device Identifier: 00643169856714
• UDI-Public: (01)00643169856714(17)250328(10)GFER0769
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/15/2020
• Report Date (Section F): 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 007042
• Device Lot Number: GFER0769
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79
• Date Report Sent to FDA: 07/15/2020