BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 1935469 · Received December 21, 2010

    Report

    Report Number
    1820334-2010-00674
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 24, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER QUALITY CONTROL SPECIFICATION, THERE IS 100% INSPECTION CONFIRMING THE FLARE ON PROXIMAL END OF SHEATH IS CAUGHT SECURELY IN PROXIMAL FITTINGS AND THAT THE SHEATH DOES NOT ROTATE IN THE CAP FITTING. IT IS ALSO VERIFIED THAT THE COILS IN SHEATH CONTINUE INTO CAP. IN ADDITION, THERE IS AN IFU THAT IS PROVIDED THAT INFORMS THE END USER THAT ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. UPON INSPECTION OF THE RETURNED DEVICE, IT WAS EVIDENT THE CAP HAD SEPARATED FROM THE SHEATH WITH THE FLARE INTACT; HOWEVER, THE FLARE WAS TOO SMALL. ON (B)(6) 2010, A CHANGE REQUEST FOR THE USE OF TORQUE LIMITING DEVICES FOR THE ATTACHMENT OF PROXIMAL FITTINGS ON FLEXOR SHEATHS < 9.0FR WAS IMPLEMENTED. COMPLAINT DEVICE WAS MFG PRIOR TO NOTED CHANGE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    WHILE REMOVING THE DEVICE, THE CHECK FLO HUB POPPED OFF OF THE SHEATH. BLOOD CAME POURING OUT. WHILE THERE WAS NO HARM TO THE PT, THE PHYSICIAN WAS VERY ANNOYED. CONFIRMED THAT A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2569601

    Patients

    Seq Age Sex Outcome Treatment
    1