BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM

    MDR report key: 4922750 · Received July 17, 2015

    Report

    Report Number
    2518433-2015-00008
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EXAMINATION OF THE CASE DATA PROVIDED BY THE CUSTOMER. THE CONSOLE WAS NOT RETURNED. A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. THE SENIOR ALGORITHM SCIENTIST PERFORMED A REVIEW OF THE SAVED PROCEDURE DATASET AND DETERMINED THAT THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS IN THE OPERATOR'S MANUAL. THE OPERATOR SHOULD NOT HAVE REMOVED AND REINSERTED THE STYLET IN THE VESSEL WHILE PERFORMING THE PROCEDURE. ADDITIONALLY, THE OPERATOR DID NOT STOP THE CATHETER PLACEMENT PROCEDURE WHEN THE VPS SYSTEM CONTINUOUSLY DISPLAYED A BLUE BULLSEYE SYMBOL. USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. A CUSTOMER IN-SERVICE WAS REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO A PATIENT IN THE VASCULAR ACCESS AREA. DURING THE PROCEDURE, THEY RECEIVED A BLUE BULLSEYE BUT AFTER A CHEST X-RAY THE CATHETER WAS NOT IN THE LOWER SVC BUT SHOWED IN THE SUBCLAVIAN. THE PATIENT WAS HUNCHED OVER AND THE CLINICIAN WAS NOT ABLE TO FLATTEN THE PATIENT OUT DURING INSERTION AND DUE TO THIS PROCEEDED WITH THE CHEST X-RAY. THE CLINICIAN HAD DIFFICULTY THREADING THE CATHETER WITH THE BIOSENSOR SO THEY PULLED THE MARKED BIOSENSOR OUT OF THE PICC. THEY THEN PLACED THEIR FLOPPY INSERTION WIRE IN THE CATHETER AND ATTEMPTED TO RE-THREAD THE CATHETER. AFTER THEY THREADED THE CATHETER, THEY PULLED THE FLOPPY INSERTION WIRE OUT AND ATTEMPTED TO RE-THREAD THE BIOSENSOR. THE BIOSENSOR WOULD NOT THREAD WELL AND THEY WERE NOT ABLE TO GET THE LAST 10CM OF THE BIOSENSOR THREADED. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. THE CLINICIAN USED A SINGLE LUMEN BIOFLO PICC AND NEITHER THE CATHETER NOR THE SENSOR IS AVAILABLE AND THE LOT NUMBERS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466452 VASCULAR POSITIONING SYSTEM VPS G4 SYSTEM OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1