BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITREX NITINOL GUIDEWIRE

    MDR report key: 6628903 · Received June 8, 2017

    Report

    Report Number
    2183870-2017-00244
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    April 7, 2017
    Report Date
    May 10, 2017
    Manufacturer
    COVIDIEN
    Product Code
    DQX
    PMA / PMN Number
    K040345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: AS RECEIVED, THE SPECIMEN CONSISTS OF ONE-1 EACH MJNCCA-X, INT 180-014; RETURNED RELOADED INTO THE DISPENSER ASSEMBLY AND DOUBLE-BAGGED WITHIN "ZIP-LOCK" STYLE POLY BIOHAZARD POUCHES. DIMENSIONAL VERIFICATION: AS RECEIVED, THE SPECIMEN PRESENTS AN OVERALL LENGTH OF 180.35CM, AN ANGLED TIP LENGTH OF 0.426CM/.168", A SHAFT DIAMETER OF .01290" TO .01295", AND A TIP ANGLE OF 18.4°. THE MISSING COIL PREVENTS VERIFYING THE COIL LENGTH AND DIAMETER. A GAGE BUSHING CERTIFIED TO BE .0140" PASSED OVER THE LENGTH OF THE SPECIMEN. OBSERVATION FINDINGS: THE SPECIMEN PRESENTS A MISSING DISTAL COIL WITH SEVERAL BENDS OVER THE DISTAL 35CM OF THE EXPOSED CORE WIRE. THE JOINT REGIONS PRESENT ADHESIVE REMNANT MATERIAL INDICATING THE PRESENCE OF THE ADHESIVE JOINTS PRIOR TO THE INCURRED DAMAGE. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT.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.

    Description of Event or Problem · 1

    A PHYSICIAN TRIED TO USE A NITREX NITINOL GUIDEWIRE FOR A PTA PROCEDURE. IT WAS REPORTED THAT THE DISTAL TIP OF THE GUIDEWIRE WAS BENT AND SPLIT DURING THE PROCEDURE. THE TIP DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER NITREX GUIDEWIRE. NO INJURY TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408940 NITREX NITINOL GUIDEWIRE WIRE, GUIDE, CATHETER DQX COVIDIEN N141802 10470698

    Patients

    Seq Age Sex Outcome Treatment
    1