BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 1173368 · Received September 22, 2008

    Report

    Report Number
    1820334-2008-00526
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED IN A USED AND DAMAGED CONDITION. A VISUAL EXAMINATION CONFIRMED THE PROXIMAL END OF THE MATERIAL, INCLUDING THE FLARE HAS SEPARATED FROM THE CHECK-FLO ASSEMBLY. THIS PRODUCT GROUP IS INSPECTED 100% FOR BENDS, KINKS, PROPER SECUREMENT OF PROXIMAL FITTINGS AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. AT THIS TIME, THE CAUSE OF THE HUB SEPARATION IS UNABLE TO BE DETERMINED. A SEARCH OF OUR RECORDS DISCOVERED THIS DEVICE WAS MANUFACTURED PRIOR TO AN IMPLEMENTATION OF A CHANGE IN PROCESSING ENSURING THE CAP HAS BEEN SECURELY TIGHTENED TO THE CHECK-FLO AND/OR ADAPTER. NEVERTHELESS, THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING A THROMBOLYSIS OF THE RIGHT SFA FROM A CONTRALATERAL APPROACH USING UROKINASE WITH INDICATION - CLAUDICATION, THE HUB SEPARATED FROM THE INTRODUCER AT THE END OF THE PROCEDURE ON A MALE PT. WITH A WIRE IN PLACE AT THE TIME, THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE AND REPLACE THE INTRODUCER WITH SOME BLEEDING AS THE ONLY COMPLICATION. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2066924

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention