BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR GUIDING SHEATH

    MDR report key: 2221809 · Received August 17, 2011

    Report

    Report Number
    1820334-2011-00448
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FITTING SEPARATION IS NOT LABELED IN THE IFU. BOTH DEVICES WERE 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 FLEXOR CHECK-FLO II INTRODUCER INSPECTION PROCESSES CONSISTS OF USING 100% INSPECTION TO 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. FURTHERMORE, INSTRUCTIONS FOR USE (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. FOR THIS PRODUCT FAMILY AND FAILURE MODE, INTERIM CORRECTIVE ACTION WAS IMPLEMENTED VIA A CHANGE REQUEST ON (B)(4) 2010. A COPY OF THE WORK ORDER FOR THE PROVIDED LOT SHOWS THAT THIS DEVICE WAS FLARED ON (B)(4) 2010 PRIOR TO IMPLEMENTATION DATE. 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

    AFTER INITIALLY PREPPING THE PRODUCT THE CUSTOMER PUT THE DILATOR INSIDE THE SHEATH AND ADVANCED THE ENTIRE SYSTEM OVER THE WIRE. UPON INSERTION INTO THE GROIN, THE BLUE PART OF THE FLEXOR SHEATH DETACHED FROM THE HUB. THE INITIAL PRODUCT (1820334-2011-00447) WAS REMOVED, NO HARM TO PT, PREPPED ANOTHER DEVICE (1820334-2011-00448) AND THE SAME THING HAPPENED. THE CUSTOMER USED A DIFFERENT COOK SHEATH TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. NO HARM TO 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 GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC NA 2451945

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN