BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 5100554 · Received September 24, 2015

    Report

    Report Number
    1820334-2015-00615
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    August 8, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, TRENDS, AND QUALITY CONTROL DOCUMENTATION REVIEW OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. TWO RYCFW-6.0-35-6-RB-CW INTRODUCERS WERE RETURNED WITH THE DILATOR INSERTED INTO THE VALVE. BOTH DEVICES WERE LEAK TESTED BY OCCLUDING THE DEVICE USING HEMOSTATS. BOTH DEVICES CONFIRMED TO LEAK AROUND THE 10189 SILICONE DISC AND OUT OF THE CENTER OF THE 5512 CAP. ASSUMING BOTH DEVICES ARE FROM THE LOT NUMBER ON THE TAG, 5964945. THE OTHER TWO DEVICES MENTIONED IN THE COMPLAINT DESCRIPTION WERE NOT RETURNED AND THE LOT NUMBERS ARE UNKNOWN. PREVIOUS INVESTIGATION OF THIS PRODUCT HAS FOUND THAT EXCESSIVE GLUE HAS PREVIOUSLY BEEN USED WHEN ASSEMBLING THE CHECK-FLO "Y" BODY, WHICH CAN CAUSE LEAKAGE SIMILAR TO WHAT WAS FOUND WHILE LEAK TESTING.

    Description of Event or Problem · 1

    THE PRODUCT LEAKS AT THE CHECK FLO VALVE WHEN FLUSHING PRIOR TO AND DURING THE PROCEDURE. THERE WAS NO SIGNIFICANT BLOOD LOSS. THE PROCEDURE WAS COMPLETED USING ANOTHER COOK SHEATH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632346 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1