BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VASCULAR POSITIONING SYST

    MDR report key: 3868005 · Received May 9, 2014

    Report

    Report Number
    3006795936-2014-00008
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 7, 2014
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE CATHETER WAS BEING PLACED INTO THE LEFT BASILIC VEIN OF A (B)(6) MALE PATIENT, (B)(6). WITH A MALIGNANT NEOPLASMA OF BONE IN BONE MARROW, COPD, AND CORONARY ARTERY DISEASE IN THE INTENSIVE CARE UNIT. THE CATHETER WAS INSERTED AND THE CLINICIAN OBTAINED A BLUE BULLS EYE. POST INSERTION A CHEST X-RAY WAS ORDERED AND REVEALED THAT THE CATHETER WAS IN THE VENTRICLE. AS A RESULT, THEY ORDERED THE CATHETER BE PULLED BACK 5CM. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT AND THERE WAS NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282088 VASONOVA VASCULAR POSITIONING SYST CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC. VPS-G4C

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR