BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULAR POSITIONING SYSTEM

    MDR report key: 4929854 · Received July 21, 2015

    Report

    Report Number
    2518433-2015-00007
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 7, 2015
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EVALUATION OF THE RETURNED CONSOLE AND DATASET. THE X-RAY MENTIONED IN THE INITIAL REPORT WAS NOT PROVIDED. THE CONSOLE WAS EXAMINED AND FOUND TO BE IN ACCEPTABLE CONDITION. THE UNIT WAS TESTED AND FUNCTIONED AS INTENDED AND A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. THE SENIOR ALGORITHM SCIENTIST REVIEWED THE SAVED PROCEDURE DATASET AND DETERMINED THAT THE OPERATOR CONTINUED TO ADVANCE THE STYLET IN THE DIRECTION OF THE HEART EVEN THOUGH THE "ORANGE STOP" SYMBOL AND ARTERIAL FLOW DOPPLER WERE CONTINUOUSLY DISPLAYED AFTER INITIAL PLACEMENT IN THE PERIPHERAL SITE. THIS WAS CONTRARY TO THE INSTRUCTIONS IN THE PROVIDED OPERATOR'S MANUAL . THEREFORE, USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. A CUSTOMER IN-SERVICE WAS REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED IN THE INTENSIVE CARE UNIT. DURING INSERTION OF A BARD 5FR TRIPLE LUMEN CATHETER THE CLINICIAN RECEIVED A BLUE BULLSEYE WITH THE VPS. ADDITIONAL INFORMATION PROVIDED BY THE TELEFLEX CLINICAL EDUCATION MANAGER INDICATES THE CLINICIAN TURNED ON VPS UNIT WHEN THEY WERE 10CM INTO THE VESSEL. INITIAL SYMBOL WAS GREEN WITH LOW AMPLITUDE ANTE-GRADE DOPPLER, THEN IT WENT ORANGE WITH RETROGRADE FLOW. KEPT TOGGLING BETWEEN GREEN AND ORANGE SYMBOLS. AFTER SEVERAL FRAMES OF RETROGRADE FLOW WITH ORANGE SYMBOL, SYMBOL TURNED GREEN AND DOPPLER BECAME HIGH AMPLITUDE ANTE-GRADE FLOW FOR SEVERAL FRAMES. THERE WERE A COUPLE FLEETING BLUE BULLSEYES FOLLOWED BY A STEADY BLUE BULLSEYE FOR AT LEAST 10 SECONDS. OVER THE WEEKEND, A SUBSEQUENT CHEST X-RAY WAS TAKEN FOR ANOTHER REASON AND READING RADIOLOGIST NOTICED THAT THE PICCC WAS OVER THE CLAVICLE AND TERMINATED ON THE LEFT SIDE OF THE HEART INDICATING AORTA PLACEMENT. VASCULAR SURGERY WAS CONSULTED, PATIENT WAS FOUND WITH NO BRACHIAL PULSE. THE PATIENT WAS TAKEN TO SURGERY FOR A THROMBECTOMY AND CATHETER WAS REMOVED. THE PATIENT HAD NO FURTHER ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472425 VASCULAR POSITIONING SYSTEM VPS G4 SYSTEM OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention