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

Catalog Number ZNGRLS180HJ

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Dissection (2491)

Event Date 08/07/2017

Event Type  Injury  

Event 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.

• Brand Name: ZINGER GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6851091
• MDR Text Key: 85271181
• Report Number: 1220452-2017-00090
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 20643169452996
• UDI-Public: 20643169452996
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K983927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2018
• Device Catalogue Number: ZNGRLS180HJ
• Device Lot Number: G15A10933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2017
• Date Device Manufactured: 12/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1