BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH-LAB SHEATH INTRO SE T:

    MDR report key: 2243869 · Received August 24, 2011

    Report

    Report Number
    9680794-2011-00060
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYB
    PMA / PMN Number
    K924607
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TEN DAYS AFTER THE SHEATH WAS PLACED, THE SIDE ARM WAS FOUND SEPARATED FROM THE HEMOSTASIS VALVE IN THE PT'S ROOM. THE SIDE ARM WAS CONNECTED TO A TRANSDUCER AND THE INSERTION SITE WAS THE FEMORAL ARTERY. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 FROM (B)(6) STATED THE SHEATH WAS INSERTED THROUGH THE FEMORAL ARTERY TO MEASURE ARTERIAL PRESSURES USING A TRANSDUCER. AFTER THE SHEATH WAS INSERTED IN THE CATH LAB, THE PT WAS IN THEIR ROOM WHERE THE EVENT OCCURRED. ONLY A SMALL AMOUNT OF BLEEDING WAS SEEN. THE SHEATH WAS USED FOR A TREATMENT AND LATER USED FOR MEASURING ARTERIAL PRESSURES. THE USER REATTACHED THE SIDE ARM TO THE VALVE AND USED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH-LAB SHEATH INTRO SE T: INTERVENTIONAL PSI PRODUCTS DYB ARROW INTERNATIONAL INC. CF1011296

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK