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

Model Number	ZNGRLS180HS
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use one zinger guidewire to treat a non calcified, moderately tortuous lesion located in the proximal diagonal artery with 90% stenosis.There was no damage noted to the device packaging.There were no issues noted removing the device from the protective hoop.The device was inspected before use with no issues noted.It was reported that damage was noted to the device and the device detached in the patient.Coil separation occurred to the distal extreme of the device.The tip of the device detached during advancement of the device.The procedure was completed using a same sized zinger guidewire.No patient injury was reported.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 12299467
• Report Number: 1220452-2021-00032
• Device Sequence Number: 11679647
• Product Code: DQX
• UDI-Device Identifier: 00643169452985
• UDI-Public: 00643169452985
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K983927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 05/09/2023
• Device Model Number: ZNGRLS180HS
• Device Catalogue Number: ZNGRLS180HS
• Device Lot Number: G20A04672
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR