BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM - REFURB

    MDR report key: 4892066 · Received July 6, 2015

    Report

    Report Number
    2518433-2015-00004
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EVALUATION OF AN X-RAY IMAGE AND A DATA CASE PROVIDED BY THE CUSTOMER. THE SR. ALGORITHM SCIENTIST PERFORMED A REVIEW OF THE SAVED PROCEDURE DATASET AND CONCLUDED THAT THE EVENT WAS MAINLY DUE TO A LACK OF COMPLIANCE TO THE OPERATOR'S MANUAL, SPECIFICALLY CONTINUOUS ADVANCEMENT OF THE CATHETER/STYLET EVEN AFTER A CLEAR BLUE BULLSEYE WAS DISPLAYED. A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. BASED ON THESE RESULTS, USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. A CUSTOMER IN-SERVICE HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE RIGHT BASILIC VEIN OF A PATIENT WITH THE USE OF VPS. A BLUE BULLSEYE WAS OBTAINED AND A CHEST X-RAY WAS NOT ORDERED. AFTER THE CATHETER WAS IN USE A FEW HOURS, THE ATTENDING PHYSICIAN ORDERED A CHEST X-RAY. THE CATHETER WAS IN THE PATIENT'S RIGHT ATRIUM. AS A RESULT, THE CATHETER WAS PULLED BACK 4CM. 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
    437305 VASCULAR POSITIONING SYSTEM - REFURB CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1