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

Catalog Number	ZNGRLS180HJ
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	08/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that the wire is hard, bad torque, tends to dissect the artery with ease.Patient presented with aortic dissection when wire was used.Wire discarded.

• Brand Name: ZINGER GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6851084
• Report Number: 1220452-2017-00089
• Device Sequence Number: 60265
• Product Code: DQX
• UDI-Device Identifier: 20643169452996
• UDI-Public: 20643169452996
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K983927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2018
• Device Catalogue Number: ZNGRLS180HJ
• Device Lot Number: G15A10933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1