BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RAABE GUIDING SHEATH

    MDR report key: 2232614 · Received August 26, 2011

    Report

    Report Number
    1820334-2011-00456
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 2, 2011
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOREIGN BODY REMOVAL IS NOT LABELED IN THE IFU, (B)(4) BLOOD LOSS IS NOT LABELED IN THE IFU. (B)(4) DEVICE BREAKAGE IS LABELED IN THE IFU. THE DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION: THE SHEATH HAD BEEN PULLED THROUGH THE CAP WITH THE APPROPRIATE SIZED FLARE INTACT; AND THE SHEATH HAD SEPARATED AT A POINT APPROX 50 CM DISTAL FROM THE HUB EXPOSING THE COIL AND PULLING OUT SEGMENTS OF THE LINER. THE FLEXOR CHECK-FLO II INTRODUCER IS INSPECTED USING 100% INSPECTION, CONFIRM FLARE ON PROXIMAL END OF SHEATH IS CAUGHT SECURELY IN PROXIMAL FITTINGS AND THE SHEATH DOES NOT ROTATE IN CAP FITTING. IT IS ALSO VERIFIED THAT COILS IN SHEATH CONTINUE INTO CAP. IN ADDITION, AN INSTRUCTIONS FOR USE (IFU) IS PROVIDED THAT INFORMS THE END USER THAT ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. VISUAL EXAMINATION REVEALED THE CAP HAD SEPARATED FROM THE SHEATH, WHICH HAD ALSO SEPARATED APPROX 50 CM DISTAL FROM THE HUB, EXPOSING THE INNER COIL AND LINER; HOWEVER, THERE IS NO INDICATION THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. IN ANY CASE, DAMAGE TO THIS EXTENT IS INDICATIVE OF EXCESSIVE FORCES ENCOUNTERED BEYOND THE DEVICES DESIGN STRENGTH, WHICH HAS BEEN VERIFIED THROUGH TESTING TO MEET THE (B)(4) STANDARD. THE REASON FOR SUCH EXCESSIVE FORCE MAY HAVE BEEN DUE TO: PT ANATOMY - SCAR TISSUE AT THE ENTRY SITE, TORTUOUS VASCULATURE AND/OR CALCIFIED LESIONS IN THE ARTERY; AND/OR ANOTHER DEVICE - DIFFICULTY IN ADVANCING THE EV3 EMBOLIZATION PROTECTION DEVICE (SPIDERX) MAY HAVE OCCURRED AS THE MFR'S WEB SITE FOR THEIR NEWEST VERSION (SPIDEFX) STATES IT, "... REDUCES MAXIMUM FORCE REQUIRED TO PUSH FILTER BY AN AVERAGE OF 40% COMPARED TO SPIDERX". HOWEVER, THE INNER DIAMETER OF THE 8FR COOK INTRODUCER SHEATH IS MUCH LARGER THAN THE 0.066" MINIMUM SPECIFIED BY EV3 FOR DEVICE COMPATIBILITY. 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. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. RELEVANT TO THIS FAILURE MODE OF HUB SEPARATION, THIS DEVICE WAS MANUFACTURED AFTER THE IMPLEMENTATION OF CAPA (B)(4). IN ADDITION, PREVENTIVE ACTION WAS INITIATED FOR PROXIMAL FITTING SEPARATION FROM SHEATHS, AT MGMT DISCRETION PRIOR TO THE RECEIPT OF THIS COMPLAINT.

    Description of Event or Problem · 1

    DURING AN ANGIOGRAPHY PROCEDURE, THE RADIOLOGIST WAS UTILIZING A FLEXOR RAABE GUIDING SHEATH. THE PT HAD A LOT OF SCAR TISSUE IN THE GROIN. DURING THE PROCEDURE, WHILE A SPIDER X WAS ADVANCED THROUGH THE SHEATH, AT SOME POINT THE SIDE ARM CAME OFF OF THE SHEATH AND THEN THE SHEATH BEGAN TO UNRAVEL. AS THE RADIOLOGIST TRIED TO REMOVE THE SHEATH, THE TIP REPORTEDLY BROKE OFF AND HAD TO BE RETRIEVED. THE TIP, WRAPPED IN A SEPARATE TISSUE, WILL BE RETURNED IN THE PACKAGING WITH THE SHEATH. PT EXPERIENCED BLOOD LOSS DUE TO THE PRODUCT FAILURE AND EXTENDED TIME ON THE TABLE. THEY HAD TO PERFORM AN ADDITIONAL PROCEDURE TO REMOVE THE FOREIGN BODY WHICH RESULTED FROM THE SHEATH BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC NA 2754047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention