BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM

    MDR report key: 3972911 · Received April 28, 2014

    Report

    Report Number
    3006795936-2014-00007
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    VASONOVA INC
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED FOR THE PATIENT IN THEIR ROOM. THEY WERE USING THE BIOSENSOR WITH A BARD 6FR POWER PICC SOLO. AN EXPERIENCED PICC NURSE WAS PLACING THE CATHETER WITH THE USE OF THE VPS AND HAD EXCELLENT DOPPLER FLOW. THE ANTI-GRADE FLOW SIGNATURE WAS SEEN AS WELL AS THE HEAR VALVES WERE CLEARLY AUDIBLE. THE CASE ENDED ON A STEADY BLUE BULLS EYE. A CHEST X-RAY WAS PERFORMED AND REVEALED THE CATHETER TIP WAS IN THE CONTRA-LATERAL INTERNAL JUGULAR. THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY TO HAVE THE CATHETER REPOSITIONED. IT WAS NOTED THEY WERE USING A VPS7220B FROM LOT 19F13L0037. THEY ALSO NOTED THEY HAVE DONE APPROXIMATELY 30 TO 40 CASES AND HAVE HAD GREAT SUCCESS BLUE BULLS EYES AND NON-BLUE BULLS EYE CASES. THERE WAS NO DELAY IN THERAPY AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254199 VASCULAR POSITIONING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 VPS7220B BIOSENSOR, BARD 6 FR POWER PICC SOLO