BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VASCULAR POSITIONING SYSTEM

    MDR report key: 3888294 · Received April 15, 2014

    Report

    Report Number
    3006795936-2014-00006
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE CATHETER WAS BEING PLACED INTO THE PATIENT'S ARM IN IV THERAPY. DURING PLACEMENT, THE NURSE WAS ATTEMPTING TO REPOSITION THE BIOSENSOR. SHE PULLED BACK ON THE BIOSENSOR AND IT SPLIT EXPOSING THE TWO INNER WIRES FOR ABOUT A SIX INCH SPACE. THE TWO SECTIONS DID NOT COMPLETELY SEPARATE, HOWEVER, THE SENSORS IN THE BIOSENSOR NO LONGER FUNCTIONED. AS A RESULT, A NEW BIOSENSOR WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230652 VASONOVA VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1