BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 4188050 · Received October 17, 2014

    Report

    Report Number
    2134070-2014-00181
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    PMA / PMN Number
    K110076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH A PORTION OF THE OUTER COATING TORN/WORN/SCRATCHED AWAY EXPOSING THE WIRE BRAIDING AND CREATING ROUGH SURFACES. THE DEVICE WAS COILED AND HAD SEVERAL KINKS IN THE LENGTH OF THE SHAFT. UPON EVALUATION, THE DEVICE DID NOT PASS THE STRAIGHTNESS (CENTERLINE) TEST, WHICH WAS POSSIBLY DUE TO THE MANNER IN WHICH THE DEVICE WAS RETURNED. THE MOBILITY OF THE DEVICE WAS ALSO AFFECTED; THE DEVICE DID NOT FULLY DEFLECT AS INTENDED. THE DEVICE WAS ELECTRICALLY TESTED AND FAILED THE ACOUSTIC VERIFICATION/CALIBRATION TEST, BUT PASSED ALL OTHER ELECTRICAL TESTING INCLUDING HI-POT, SIGNAL STRENGTH AND ULTRASOUND TESTING. THE DAMAGE TO THE OUTER COATING OF THE SHAFT WAS POSSIBLY DUE TO THE DEVICE BEING PACKAGED FOR RETURN WITHOUT BEING ADEQUATELY SECURED CAUSING EXCESS FRICTION DURING RETURN SHIPPING. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A DEFECTIVE STEERING MECHANISM. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. THER WERE NO PATIENT CONSEQUENCES. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON INVESTIGATION. IT WAS LATER REPORTED THAT THE ISSUE WS DISCOVERED ALMOST IMMEDIATELY DURING MAPPING. NO BREACH IN THE DEVICE INSULATION WAS NOTICED DURING THE PROCEDURE. THE DEVICE WAS PLACED ON THE BACK TABLE AFTER BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660384 NA REPROCESSED INTRAVASCULAR ULTRASOUND OWQ STERILMED, INC. BIOSNDSTR10 1704304

    Patients

    Seq Age Sex Outcome Treatment
    1