BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE SET

    MDR report key: 3972929 · Received April 28, 2014

    Report

    Report Number
    9680794-2014-00101
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ARROW INTERNACIONAL INC.
    Product Code
    MCW
    PMA / PMN Number
    K990829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PTD WAS BEING USED TO PERFORM A DECLOT ON A FEMALE PATIENT'S LEFT BASILIC FISTULA. THE INTERVENTIONAL NEPHROLOGIST WAS USING THE DEVICE IN AN OUTFLOW VEIN AND THE DEVICE BECAME STUCK. HE DETACHED THE CATHETER FROM THE ROTATOR DRIVE UNIT AND ATTEMPTED TO ROTATE THE BASKET COUNTER CLOCKWISE, BUT WAS UNSUCCESSFUL. THE FISTULA, TO HIS KNOWLEDGE, WAS ONLY THREE MONTHS OLD. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT AT ANOTHER HOSPITAL AND A VASCULAR SURGEON WAS BROUGHT IN TO REMOVE THE PTD. HE ALSO DETACHED THE CATHETER FROM THE ROTATOR DRIVE UNIT AND MANUALLY ROTATED THE BASKET COUNTER CLOCKWISE. INITIALLY IT DID NOT WORK, HOWEVER, THE VASCULAR SURGEON WAS ABLE TO MANUALLY UNTANGLE THE DEVICE AND REMOVE IT. THE VEIN WAS CLOTTED AND HE BALLOONED IT. HE FEELS IT MAY HAVE BEEN STUCK ON A VALVE. THE PATIENT IS CURRENTLY FINE WITH A WORKING FISTULA. THE VASCULAR SURGEON MENTIONED THIS WAS NOT A GOOD FISTULA TO BEGIN WITH. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT AND THERE WAS NO PATIENT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED THE PROCEDURE TOOK LONGER THAN NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254202 PERCUTANEOUS THROMBOLYTIC DEVICE SET PTD PRODUCTS MCW ARROW INTERNACIONAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1