BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER GUIDING SHEATH

    MDR report key: 2082633 · Received April 27, 2011

    Report

    Report Number
    1820334-2011-00196
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 28, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (DAMAGE POSSIBILITY TO DEVICE). THE INTRODUCER WAS RETURNED IN A USED AND DAMAGED CONDITION. THE CAP HAD SEPARATED FROM THE SHEATH AND THE CROSS SECTION OF THE FLARE WAS NO LONGER CIRCULAR, BUT MORE IN THE SHAPE OF A FLEUR-DE-LIS. ALSO, THE SHEATH WAS KINKED CIRCUMFERENTIALLY ABOUT 1CM DISTAL OF THE FLARE. THE FLARE APPEARS TO BE SMALL. THE CHECK-FLO CAP HAD ALSO SEPARATED FROM THE CHECK-FLO BODY AND THE SILICONE DISK IS MISSING. PER QUALITY CONTROL INSTRUCTIONS, "IN-PROCESS AND FINAL INSPECTION FOR CHECK-FLO INTRODUCER", INSTRUCTIONS ARE TO INSPECT 100% TO CONFIRM CHECK-FLO FITTINGS ARE FULLY SNAPPED AND SECURE BY MANUALLY TUGGING ON FITTINGS. VISUALLY EXAMINE AND CONFIRM FLARE OF SHEATH IS CAUGHT SECURELY IN CHECK-FLO ASSEMBLY. SHEATH MUST NOT ROTATE IN FITTINGS. THE SHEATH MATERIAL IS ALSO INSPECTED BY MEASURING THE INSIDE DIAMETER OF THE MATERIAL. INSTRUCTIONS FOR USE (IFU) INCLUDES THE FOLLOWING PRECAUTION: "ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT." THE MANUFACTURING INSTRUCTIONS FOR LARGE CHECK-FLO INTRODUCER SHEATH STATES TO FLARE PROXIMAL END OF SHEATH USING SPECIFIED FLARING IRON. THE CAP HAD SEPARATED FROM THE SHEATH AND THE CROSS SECTION OF THE FLARE WAS NO LONGER CIRCULAR, BUT MORE IN THE SHAPE OF A FLEUR-DE-LIS. ALSO, THE SHEATH WAS KINKED CIRCUMFERENTIALLY ABOUT 1CM DISTAL OF THE FLARE. QUALITY CONTROL VERIFIES THE SHEATH DOES NOT ROTATE IN THE FITTING. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT AND WE CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE. QUALITY ENGINEERING RISK ANALYSIS (QERA) WAS COMPLETED BY QUALITY ENGINEERING AND CONCLUDED THAT THE RISK REMAINS ACCEPTABLE FOR THIS FAILURE MODE AND PRODUCT FAMILY.

    Description of Event or Problem · 1

    THE VALVE SEPARATED FROM THE INTRODUCER WHICH CAUSED THE DOCTOR TO PULL THE DEVICE OUT RAPIDLY WITHOUT USING ANY PRECAUTIONS, WHICH CAUSED THE PATIENT TO LOSE A LOT OF BLOOD WHICH SPRAYED ONTO THE FACES OF THE PEOPLE OPERATING. PATIENT OUTCOME WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMER GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F2559327

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other