MAUDE Adverse Event Report: MEDTRONIC, INC. NITREX NITINOL GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number	N183002
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	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that an attempt was made to use a nitrex guidewire to treat a calcified lesion in the left proximal superficial femoral artery.Degree of tortuosity was moderate.Degree of calcification was severe.Lesion stenosis was 90%.Lesion length was 80mm.Artery/vein diameter was 5mm.There were no abnormalities reported in relation to anatomy.A 7x45 terumo destination sheath was used.Embolic protection was not used.The vessel was pre-dilated with a medtronic pacific plus balloon.The vessel was post-dilated with a medtronic nanocross balloon.Device did not pass through a previously deployed stent.Severe resistance was encountered.Excessive force was not used.Ifu was followed without issue.Wire damage occurred.While attempting to cross the lesion, the tip of the nitrex wire detached in the patient¿s left profunda artery.Several attempts were made to remove the detached tip with a goose neck snare.Part of the detached tip came out, but a portion of the tip still remained.Physician was unable to perform atherectomy to the lesion because of the detached tip.The physician decided to leave the tip of the wire inside the patient and bring them to the hospital in two weeks for an endarterectomy and the wire tip will be removed at that time.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the patient was taken to surgery for an endarterectomy procedure, and the tip of the wire was removed at that time.The patient is doing well.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
Product analysis dimensional verification: the overall length of the specimen cannot be confirmed as a portion of the tip was reported to still be within the patient.The distal portion of the received specimen length cannot be measured based on as received condition.The proximal portion of the received specimen presented an overall length of 295.1cm, a finished shaft diameter of.01715¿ to.01720¿.A gage bushing certified to be.0180¿ cannot be passed over the length of the specimen due to the as received condition.Observation findings: the distal portion of the received specimen presented a ductile tensile overload core fracture at 1.2 cm from the distal tip along with stretched coil damage and traces of dried blood.The specimen also presented multiple coil wire fractures.The proximal portion of the received specimen presented bend damage at 1.6 cm from the distal aspect of the core wire fracture.The proximal coil to core joint appeared to be intact and correct.Except where noted, the specimen device appeared visually and dimensionally correct.Conclusion: the reported event "wire damage occurred.While attempting to cross the lesion, the tip of the nitrex wire detached in the patient¿s left profunda artery." could be confirmed.The device was returned in two separate pieces, the distal portion of the received specimen presented a ductile tensile overload core fracture along with stretched coil damage.The specimen also presented multiple coil wire fractures.The proximal portion of the received specimen presented bend damage at 1.6 cm from the distal aspect of the core wire fracture.The damage appeared consistent with the distal tip of the nitrex entering a constrained condition sustaining the overload fracture and coil damage when the wire was withdrawn from the constrained condition.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: NITREX NITINOL GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20471089
• Report Number: 2182208-2024-04495
• Device Sequence Number: 18043162
• Product Code: DQX
• UDI-Device Identifier: 00763000185459
• UDI-Public: 00763000185459
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K040345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2025

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 Catalogue Number: N183002
• Device Lot Number: 8989959
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 01/09/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/13/2024; 01/14/2025
• Date Device Manufactured: 07/15/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown