BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITREX NITINOL GUIDEWIRE

    MDR report key: 6428594 · Received March 23, 2017

    Report

    Report Number
    2183870-2017-00139
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    February 23, 2017
    Report Date
    May 5, 2017
    Manufacturer
    COVIDIEN
    Product Code
    DQX
    UDI-DI
    00821684065266
    PMA / PMN Number
    K040345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE CONSISTS OF ONE-1 EACH MJNCCA-X, INT 180-014; RETURNED RELOADED INTO THE DISPENSER ASSEMBLY. THE SPECIMEN PRESENTS AN OVERALL LENGTH OF 180.05 CM, A SHAPED TIP LENGTH OF .425 CM/0.167¿, A SHAFT DIAMETER OF .01290¿ TO .01295¿. THE COIL DIMENSIONS CANNOT BE VERIFIED AT THIS TIME. A GAGE BUSHING CERTIFIED TO BE .0140¿ WAS PASSED OVER THE LENGTH OF THE SPECIMEN. THE DEVICE PRESENTS A TENSILE, SHEAR OVERLOAD OF THE DISTAL COIL TO CORE WIRE JOINT AND A TENSILE OVERLOAD OF THE PROXIMAL COIL TO CORE WIRE JOINT, RESULTING IN COMPLETE REMOVAL OF THE COIL WIRE FROM THE CORE WIRE AND A RELAXED TIP ANGLE, WITH ADHESIVE REMNANT PRESENT ON THE CORE WIRE AT THE JOINT REGIONS. THE MISSING COIL SEGMENT WAS NOT RETURNED WITH THE SPECIMEN. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT.

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO USE A NITREX WIRE IN THE TREATMENT OF A PATIENT AT THE MID TIBIAL/POPLITEAL TRUNK. TARGET LESION TYPE WAS CALCIFIED WITH NO TORTUOSITY, SEVERE CALCIFICATION AND 100% STENOSIS (CTO). IT IS REPORTED THAT TIP DETACHED AT THE TARGET LESION. NO ATTEMPT WAS MADE TO REMOVE THE DETACHED COMPONENT. TIP LAYS ABOVE THE CALCIUM PLAQUE. PHYSICIAN CANNOT REANALYZE THE ARTERY DUE TO CTO AND THE PHYSICIAN STATED THERE IS NO INTERVENTION NECESSARY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210827 NITREX NITINOL GUIDEWIRE WIRE, GUIDE, CATHETER DQX COVIDIEN 10699696 00821684065266

    Patients

    Seq Age Sex Outcome Treatment
    1