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

Catalog Number	ZNGRMS180HJ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Arrhythmia (1721); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A zinger wire was intended to be used during a crt implant procedure.No damage noted to packaging.No issues removing the device from the packaging as per ifu.The device was inspected with no issues.The guide wire was flushed before use.The wire tip was not formed by the physician.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during insertion/delivery.During a crt implant, the right atrial lead and the right ventricle lead were in place.The zinger was advanced in order to place the left ventricular lead.Since the desired position was not reached, the operator wanted to retract the lead but it was not possible.An attempt was made to advance the lead over the guidewire in order to try to loosen the zinger, but it was not possible as the wire was stuck in the anterior branch.As the zinger was pulled in, there was a lot of resistance and the patient developed ventricular arrhythmia.The entire zinger wire was left in the patient, and the patient was sent for surgical extraction of the zinger in another hospital with thoracic surgery backup.The removal attempt was unsuccessful a part of the wire was teared off, and part of the wire remains between the posterolateral vein and the coronary sinus ostium.The patient is reported to be alive without further injury.
Additional Manufacturer Narrative
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: 8226399
• Report Number: 1220452-2019-00005
• Device Sequence Number: 217169
• Product Code: DQX
• UDI-Device Identifier: 20643169452668
• UDI-Public: 20643169452668
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140695
• 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): 04/08/2019

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: 03/23/2019
• Device Catalogue Number: ZNGRMS180HJ
• Device Lot Number: G16A02425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention