BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 2240937 · Received August 9, 2011

    Report

    Report Number
    1820334-2011-00430
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FITTING SEPARATION IS NOT SPECIFICALLY ADDRESSED IN THE IFU. COMPLAINT DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION. AN EXAMINATION CONFIRMED THE PROXIMAL FITTING (CAP AND ADAPTER) HAD SEPARATED FROM THE SHEATH WITH THE FLARE INTACT, ALTHOUGH IT WAS OF IRREGULAR SHAPE HAVING BEEN PULLED THROUGH THE CAP. THE FLARE APPEARED TO BE UNDERSIZED PER SPECIFICATION. SHEATH WAS OTHERWISE UNREMARKABLE. PER QUALITY CONTROL SPECIFICATION, THE PROXIMAL FITTINGS ARE CONFIRMED TO BE CORRECT AND THE FLARE IS CAUGHT SECURELY IN CAP ASSEMBLY. IT IS ALSO VERIFIED THAT THE SHEATH DOES NOT ROTATE AND THE COIL IN THE SHEATH CONTINUES INTO CAP. AN 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. DEVICES FROM THE COMPLAINT LOT IN THIS REPORT WERE ASSEMBLED 02/24/2011 WHICH IS AFTER THE EFFECTIVE IMPLEMENTATION DATE OF 09/15/2010 FOR A CHANGE REQUEST THAT REQUIRED (B)(4). ALTHOUGH A CAPA (CORRECTIVE ACTION/PREVENTATIVE ACTION) WAS PREVIOUSLY ISSUED AT MANAGEMENT DISCRETION FOR THIS FAILURE MODE OF FITTING SEPARATION) AND PRODUCT FAMILY PRIOR TO THIS OCCURRENCE, THE UNDERSIZED FLARE MOSTLY CONTRIBUTED TO THE DESCRIBED FAILURE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS OCCURRENCE AND WE ARE CONTINUING OUR MONITORING OF COMPLAINTS FOR THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE PHYSICIAN SELECTED FLEXOR SHUTTLE TIBIAL GUIDING SHEATH FOR PTA OF LOWER LEG. WHEN HE INSERTED THE CATHETER INTO THE LEFT BRACHIAL ARTERY, THE HUB GOT SEPARATED BUT THE PHYSICIAN PUT IT BACK INTO THE POSITION AND CONTINUED THE PROCEDURE, HOLDING THE HUB BY HIS HAND. THE PATIENT DID NOT EXPERIENCE AND ADVERSE EVENTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F2622705

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN