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

Catalog Number	ZNGRS180HJ
Medical Device Problem Codes	Retraction Problem (1536); Material Distortion (2977)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7189122
• Report Number: 1220452-2018-00004
• Device Sequence Number: 16340037
• Product Code: DQX
• UDI-Device Identifier: 20643169452583
• UDI-Public: 20643169452583
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/02/2018

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: 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
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 123