BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 2221246 · Received August 17, 2011

    Report

    Report Number
    1820334-2011-00482
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HUB SEPARATION IS NOT LABELED IN THE IFU. DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION: THE CAP HAD SEPARATED FROM THE SHEATH WITH THE FLARE INTACT, OF UNIFORM CROSS SECTION AND OF ADEQUATE SIZE PER GAGE. QUALITY CONTROL INSPECTS THE FLEXOR CHECK-FLO II INTRODUCER, USING 100% INSPECTION, CONFIRMING THE FLARE ON PROXIMAL END OF SHEATH IS CAUGHT SECURELY IN PROXIMAL FITTINGS AND THAT THE SHEATH DOES NOT ROTATE IN CAP FITTING. IT IS ALSO VERIFIED THE COILS IN SHEATH CONTINUE INTO CAP. EACH FLARE IS ALSO CHECKED WITH APPROPRIATE FLARE GAUGE. FURTHERMORE, AN IFU INFORMS THE END USER THAT ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. ALTHOUGH THE FLARE WAS OF ADEQUATE SIZE, VISUAL EXAMINATION REVEALED THE CAP HAD SEPARATED FROM THE SHEATH. WHILE THIS COMPLAINT IS RELEVANT TO THE SCOPE OF CAPA FOR PROXIMAL FITTING SEPARATION FROM SHEATHS, THIS CAPA WAS ISSUED AT MANAGEMENT DISCRETION PRIOR TO THE RECEIPT OF THIS COMPLAINT. (B)(4). THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. (B)(4). WHILE RISK ANALYSIS CONCLUDED THE RISK FOR THIS FAILURE MODE AND PRODUCT FAMILY REMAINS ACCEPTABLE, PREVENTIVE ACTION WAS INITIATED FOR PROXIMAL FITTING SEPARATION FROM SHEATHS AT MANAGEMENT DISCRETION PRIOR TO THE RECEIPT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    DURING AN LSFA INTERVENTION - PTA AND STENT THE HUB OF INTRODUCER SEPARATED FROM BODY OF SHEATH. PT EXPERIENCED MINIMAL BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS AN ANGIOPLASTY BALLOON WAS REMOVED OVER THE WIRE, THE HUB SEPARATED FROM THE SHEATH AS THE DEVICE CAME BACK INTO THE SHEATH. THE PT OUTCOME WAS NOT PROVIDED BY THE RPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2528954

    Patients

    Seq Age Sex Outcome Treatment
    1