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

Catalog Number	N143001
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
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
It was reported that a physician was attempting to use a nitrex nitinol guidewire to treat a lesion in the mid popliteal artery with little tortuosity and moderate calcification a patient.The vessel was not predilated or post dilated.Ifu (instruction for use) was followed during preparation, procedure, post-procedure.It was reported that tip detached / tip damage occurred.Guidewire prolapsed did not occur causing tip damage or embolization during the procedure.The physician was trying to navigate and cross through pop artery.It was noticed that the wire looked like it ¿j¿d¿ under fluoro and the physician said some was noted resistance so pulled wire.A section of wire that detached was stuck in cxi support catheter.The catheter and detached wire were removed with no issue.Physician selected new wire and continued procedure.No patient injury reported for this event.
Additional Manufacturer Narrative
Upon investigation of the device it was discovered that the wire was not consistent with a wholey wire.The wire consisted of a black coated stainless steel core wire joined to a green ptfe coated stainless steel core wire.The distal tip region was not visible, in that it was constrained within the catheter tubing.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Upon investigation of the device it was discovered that the wire was not consistent with a nitrex wire (not wholey wire as previously reported).The wire consisted of a black coated stainless steel core wire joined to a green ptfe coated stainless steel core wire.The distal tip region was not visible, in that it was constrained within the catheter tubing.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the device was returned for analysis.The device presents an overall length of 299.10cm due to the core wire fracture, a coil length stretched to approximately 5.25cm, a shaft diameter of.01300¿ to.01305¿, and a finished coil diameter of.01300¿ to.01340¿.A gage bushing certified to be.0140¿ passed over the length of the specimen to the proximal aspect of the core damage, with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity.The specimen presents fractures of the core and coil wires.The coil wire presents indications of tensile overload with torsional loading and stretch damage from the proximal coil to core wire joint.The core wire presents spiral bend damage over the 1.50cm immediately proximal of the fracture.The core wire fracture presents indications of low cycle bending fatigue overload with tensile loading.The distal tip joint and an indeterminate amount of coil and core wire is missing from the specimen device.The proximal joint appears correct and intact.Except where noted, the specimen device appears visually and dimensionally correct.Based on the information provided and the evidence presented, it appears that clinical and/or procedural factors have contributed to the event as reported.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: 8393931
• Report Number: 2182208-2019-00436
• Device Sequence Number: 2765279
• Product Code: DQX
• UDI-Device Identifier: 00821684058121
• UDI-Public: 00821684058121
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 05/22/2019

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: 01/01/2022
• Device Catalogue Number: N143001
• Device Lot Number: 11112032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 03/26/2019; 05/09/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/23/2019; 04/23/2019; 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR