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

Catalog Number	N183002
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
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
Physician attempted to use a nitrex guidewire with a 7x45 non-medtronic (terumo destination) sheath during treatment of a calcified lesion in the patients right mid superficial femoral artery (sfa).Minimal vessel tortuosity and severe vessel calcification were reported.Lesion exhibited cto (chronic total occlusion-100%) stenosis.Artery diameter reported as 5mm.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.The vessel was not pre or post dilated.The device was not passed through a previously deployed stent.Severe resistance was encountered when advancing the device.Excessive force was not used.It was reported that the nitrex wire was removed from the patient to exchange for a different wire to help cross the lesion.When the physician examined the tip of the wire, he noticed that the wire had split at the tip, there was no component detachment.The device was safely removed from the patient.A replacement nitrex guidewire was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Product analysis dimensional verification: the specimen presented an overall length of 303.3cm with subsequent coil stretching, a finished shaft diameter of.01735¿ to.01740¿ a coil diameter of.01730¿.The coil length cannot be confirmed due to the as received condition.A gage bushing certified to be.0180¿ passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity till the proximal aspect of the fracture/shear damage of the core wire.Observation findings: the specimen presented a ductile, tensile overload fracture of the core wire at 0.6cm from the distal tip with concurrent coil stretching.The specimen also presented kink damage in the distal grind region over the 1 cm immediately proximal of the core wire fracture, consistent with tensile loading residual strain to yield.The proximal coil to core wire joint appeared to be intact and correct.Except where noted, the specimen device appeared visually and dimensionally correct.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: 20450585
• Report Number: 2182208-2024-04461
• Device Sequence Number: 8616540
• 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
• Report Date (Section B): 12/19/2024

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 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: 09/19/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown