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

Model Number	ZNGRMS180HS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: received for analysis was one zinger guidewire.The coils were stretched and unravelled.Proximal joint stretched in a distal direction.The core wire had separated from a portion of the core wire at the distal tip.Overall measurement of the wire was 178cm, indicating 2cm of the wire had detached.No kink was noted to the wire.Od measurements at joints, along spring, coated core wire wall met specification of 0.014inch maximum.No other damage was noted to the remainder of the device.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 and one attain performa lead to treat a mildly tortuous and non-calcified lesion in the cannulation of lateral veins of coronary sinus.The guidewire was inspected and prepped per ifu with no issues noted.The wire tip was not formed.The lesion was not predilated.There were no difficulties noted when loading the lead onto the guidewire.The device did not pass through a previously deployed stent.Resistance was experienced during insertion and advancing the device.Excessive force was not used.The guide wire was used during lv lead placement.The wire was placed at the target vein, lead followed the wire and immediately it was not possible to move the wire in the lead.It occurred at the beginning of procedure.It was the first placement and the first usage.Both products were removed and damage of the wire was observed.It was reported that the wire was kinked when the wire was in patient.Resistance was noted during removal of the device.It was stated that it was impossible to remove the wire from the lead.Excessive force was not used.The guidewire remained in the lead.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: annex d code added.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.
Additional Manufacturer Narrative
Updated device evaluation summary: the guidewire was not loaded in the attain performa lead.Kinks were noted on the distal end of the wire.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 11445711
• Report Number: 1220452-2021-00008
• Device Sequence Number: 4076265
• Product Code: DQX
• UDI-Device Identifier: 00643169452657
• UDI-Public: 00643169452657
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K140695
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2021

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: 12/11/2022
• Device Model Number: ZNGRMS180HS
• Device Catalogue Number: ZNGRMS180HS
• Device Lot Number: G19A12678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/23/2021; 05/11/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/20/2021; 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR