BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RTPS GUIDING SHEATH

    MDR report key: 9765399 · Received February 27, 2020

    Report

    Report Number
    1820334-2020-00489
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    May 10, 2016
    Report Date
    February 27, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002130814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION = NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = K142829. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION (B)(4), COMPLIANT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    AS REPORTED, A FIBER WAS OBSERVED ON A FLEXOR RTPS GUIDING SHEATH AT THE END OF A PROCEDURE TO REMOVE AN UNSPECIFIED INFERIOR VENA CAVA FILTER. UPON RETURN AND INVESTIGATION OF THE DEVICE, A DETACHED STRING OF THE TNRT LINER WAS FOUND. 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
    225738 FLEXOR RTPS GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G13081 6747993 00827002130814

    Patients

    Seq Age Sex Outcome Treatment
    1