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

Catalog Number ZNGRS180HJ

Device Problems Retraction Problem (1536); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Event Description

The physician was using a zinger wire when placing a medtronic lv lead.The lesion was non-calcified and non-tortuous, with no stenosis.The zinger wire was prepped per ifu.No resistance was noted when when advancing the wire in the vessel.No resistance was noted when loading the wire through the lead.No force was applied to the wire during advancement.No resistance was noted when removing the wire from the lead but the wire came out stretched like a thread, and the radio-opaque part of the wire remained in the lead.The entire lead was taken out.A new wire was used to complete the procedure.No patient injury is reported.

Manufacturer Narrative

Product analysis summary: guide wire as received is coil wrapped, stretched and the core wire is broken.Distal tip and bond joint attached by coil wire.The broken end of core wire measures 1.5mm on the proximal side of the distal bond joint.Proximal bond to the end of the broken core wire, measures approx.27cm indicating that there are no missing components or material.Distal end of wire is stretched from the proximal bond forward.If information is provided in the future, a supplemental report will be issued.

• 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: 7189122
• MDR Text Key: 97504498
• Report Number: 1220452-2018-00004
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 20643169452583
• UDI-Public: 20643169452583
• Combination Product (y/n): N
• 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,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Catalogue Number: ZNGRS180HJ
• Device Lot Number: G16A07787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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
• Patient Age: 46 YR
• Patient Weight: 123