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

Model Number	ZNGRMS180HJ
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
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.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.
Event or Problem Description
An attempt was made to use one attain lead and one zinger guidewire during a procedure in a non-tortuous, non-calcified lesion.The zinger guidewire was inspected, and no issue were observed prior of use.The guidewire was not prepped per ifu.The wire tip was not formed by the physician.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.The zinger and lead were heparinized.It was reported that the zinger guidewire broke and de-spiralized during the final lead placement in an anterolateral vessel with no tortuosity.During the extraction of the guidewire, the proximal part of guidewire came out while the distal end was still visible in fluoroscopy.It was decided to remove the lead to better understand what happened.The lumen of the vessel was obstructed; therefore, a new lead and a new guidewire were used to complete the procedure.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: the zinger guidewire became entrapped in the lumen of the lv lead.Resistance was noted during the attempt to withdraw the guidewire from the lead lumen but excessive force was not used.The detached portion of the guidewire was removed with the lead as it was blocked inside the lumen.As the detached portion was trapped inside the lumen of the lead, the guidewire and lead came out together.A new zinger guidewire was used to complete the procedure.There were no issues noted with the new guidewire used.Patient gender provided.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.
Additional Manufacturer Narrative
Product analysis summary: analysis showed the guidewire was found out of specification because it was damaged during the procedure.The guidewire was returned with the lead serial number (b)(6) and analyzed.Analysis indicated the guidewire was received detached from the lead.The distal end of the guidewire was broken and entrapped in the lead distal tip nose.The guidewire was kinked, bent, and stretched/unraveled.The guidewire was broken into two pieces when force was used to pull the guidewire from the lead.Visual analysis indicated that the guidewire was damaged during use.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: annex d code added.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ZINGER GUIDE WIRE
• Common Device Name: 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18695168
• Report Number: 1220452-2024-00013
• Device Sequence Number: 15237470
• Product Code: DQX
• UDI-Device Identifier: 20643169452668
• UDI-Public: 00643169452664
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2024

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: 01/29/2026
• Device Model Number: ZNGRMS180HJ
• Device Catalogue Number: ZNGRMS180HJ
• Device Lot Number: G23A00713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/14/2024; 03/18/2024; 04/29/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 02/27/2024; 04/09/2024; 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male