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

Model Number	ZNGRS180HJ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/08/2022
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
One zinger guide wire was attempted to be used to treat a moderately tortuous, moderately calcified lesion with high % stenosis in the distal left anterior descending (lad) artery.There was no damage noted to the device packaging.There were no issues noted when removing the device from the packaging.The device was inspected prior to use with no issues noted.The device was prepped per ifu with no issues noted.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 encountered when advancing the device.It was reported that resistance was experienced during insertion of the device into the hemostatic valve and a portion of the device detached inside the patient while trying to access the coronary sinus.The detached portion was trapped inside the patient distally.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: one zinger guide wire was received for analysis.A kink was evided to the guidewire approx.155cm distal of the proximal end.The coil had unravelled and stretched off the core wire.The core wire was kinked.The distal tip of the device had detached.No other damage noted.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
Additional information: the detachment occurred at the tip.During an attempt to cannulate a difficult posterolateral vein (coronary sinus), the guidewire got into the vein, but neither the sheath nor the sub-selector were able to cannulate that vein.When attempting to remove the guide wire a detachment occurred on the distal part of the guide wire and remains in the patient.Attempts were then made to remove the tip from the patient, but the vein where the tip detached was not possible to cannulate, then the detached part was impossible to reach, move, or remove.No other device was used to trap the tip.The tip was trapped in a stable location when the guidewire was taken out the vein.Annex g 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.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
• 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: 13522297
• Report Number: 1220452-2022-00016
• Device Sequence Number: 14549265
• Product Code: DQX
• UDI-Device Identifier: 00643169452589
• UDI-Public: 00643169452589
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 05/09/2022

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: 05/18/2024
• Device Model Number: ZNGRS180HJ
• Device Catalogue Number: ZNGRS180HJ
• Device Lot Number: G21A04325
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 02/14/2022; 04/19/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 02/25/2022; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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
• Patient Sex: Unknown