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 Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
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
Physician used a nitrex guidewire with a trailblazer device during treatment of a 230mm plaque cto (chronic total occlusion-100%) in the patient¿s mid superficial femoral artery (sfa).Moderate calcification and slight tortuosity are reported.Ifu was followed and the device was prepped without issue.The vessel was not pre-dilated.It is reported that the tip of the nitrex device was prolapsed outside.035 x 135 trailblazer in attempt to cross sfa cto.When withdrawing the wire from the trailblazer, the nitrex wire broke.The physician then removed the trailblazer with the remaining wire (with tip).No part of the wire remained in the patient.The procedure was then completed using a.035 x 260 (glidewire advantage) non-medtronic wire.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation: the specimen consists of one-1 mj-ncca-x int 300-018; returned coiled, loose and accompanied by the trailblazer device, double-bagged within ¿zip-lock¿ style poly biohazard pouches.Dimensional verification: the specimen presents an overall length of 299.10cm from the proximal aspect of the core wire fracture, the coil segment is stretched to a combined length of approximately 37cm, a shaft diameter of.01705¿ to.01710¿, a finished coil diameter of.01730¿ to.01740¿ measured at the joints.The angled tip shape appears correct and unremarkable.A gage bushing certified to be.0180¿ passed over the length of the specimen proximal of the coil damage with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity.Observation findings: the specimen presents fractures of the core and coil wires.The core wire has sustained a low cycle bending fatigue overload with tensile loading approximately 0.55cm from the distal end.The coil wire has sustained a tensile overload with torsional loading an indeterminate distance from the joints with concurrent stretching of the coil wraps prior to fracture.The core wire presents residual bend damage over the 2.5mm distal of the fracture and 3.00cm proximal of the fracture.All joints appear to be intact and correct.Deposits of dried tissue are attached to the coil wraps on the detached distal segment.Except where noted, the specimen device appears visually and dimensionally correct.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a nitrex guidewire with a trailblazer device during treatment of a 230mm plaque cto (chronic total occlusion-100%) in the patient¿s mid superficial femoral artery (sfa).Moderate calcification and slight tortuosity are reported.Ifu was followed and the device was prepped without issue.The vessel was not pre-dilated.No resistance was experienced when advancing the nitrex wire.It is reported that the tip of the nitrex device was prolapsed outside.035 x 135 trailblazer in attempt to cross sfa cto.When withdrawing the wire from the trailblazer, the nitrex wire broke.No resistance was experienced during withdrawal.The physician then removed the trailblazer with the remaining wire (with tip).The nitrex wire remained in the trailblazer.No part of the wire remained in the patient.No the procedure was then completed using a.035 x 260 (glidewire advantage) non-medtronic wire.No patient injury reported.
Additional Manufacturer Narrative
Additional information received no resistance was experienced when advancing the nitrex wire.No resistance was experienced during withdrawal.The nitrex wire remained in the trailblazer.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8137213
• Report Number: 2183870-2018-00565
• Device Sequence Number: 194917
• Product Code: DQX
• UDI-Device Identifier: 00821684058213
• UDI-Public: 00821684058213
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K040345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2019

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: 09/01/2020
• Device Catalogue Number: N183002
• Device Lot Number: 10898556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 02/20/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/04/2019; 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 68