BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTASIS VALVE/SHEATH ASSEMBLY

    MDR report key: 48369 · Received September 19, 1996

    Report

    Report Number
    2242850-1996-00042
    Event Type
    Malfunction
    Date Received
    September 19, 1996
    Date of Event
    August 21, 1996
    Report Date
    August 21, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FORM WAS COMPLETED BY THE MFR. SECTION F WAS ALSO COMPLETED BY THE MFR. NO MEDWATCH FROM WAS RECEIVED FROM THE INITIAL REPORTER OR PRODUCT USER.A 10 FRENCH, 6 INCH SEHATH/HEMOSTASIS VALVE ASSEMBLY WAS RETURNEDF TOR EVALUATION ON THE BALLOON CATHETER. VISUAO EXAMINATION REVEALED THE SHEATH TO BE KINIKED AT THE SHEATH/HUB JUNCTION. THE HEMOSTASIS VALVE GASKET WAS IN PLACE WITHIN THE VALVE. BASED ON THE CONDITION OF THE RETURNED DEVICE, IT WAS NOT POSSIBLE TO SATISTACTORILY TEST THE SHEATH/HEMOSTASIS VALVE ASSEMBLY IN THE LABORATORY. LEAKING IN THE VICINITY OF THE HEMOVALVE MAY HAVE BEEN RELATEDF TO THE KINKING OF THE SHEATH. IT WAS NOT POSSIBLE TO DRAW ANY DEFINITE CONCLUSIONS.

    Description of Event or Problem · 1

    WHEN IAB WAS INSERTED INTO THE SHEATH "BLOOD GUSHED OUT." THE CONTACT STATED THAT "IT APPEARED AS IF THERE WAS NO WHITE HEMOSTASIS VALVE" WHICH WOULD HAVE PREVENTED THE BACKFLOW OF BLOOD. THERE WAS MORE BLOOD THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTASIS VALVE/SHEATH ASSEMBLY HEMOSTASIS VALVE/SHEATH ASSEMBLY DSP DATASCOPE CORPORATION 06845401-01/0684-54-0008-03 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN