BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DESILETS-HOFFMAN SHEATH INTRODUCER

    MDR report key: 3928411 · Received June 20, 2014

    Report

    Report Number
    1820334-2014-00277
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DEVICE INFO: CATALOG: TSSW-5.0-18-MP-BERNALILLO-071879. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED THAT DURING A CORONARY ANGIO PROCEDURE, IT WAS NOTED THAT THE SHEATH WAS LEAKING AT THE HUB DURING PROCEDURES. ADDITIONAL INFORMATION RECEIVED (B)(4) 2014 - WAS NOTIFIED AFTER THE PROCEDURE THAT THE PHYSICIAN WAS PERFORMING A CORONARY ANGIO AND USING THE DEVICE AS NORMAL. AS IN PREVIOUS, THE "OUTER" SHORT SHEATH DETACHED FROM THE HUB. WHEN THIS HAPPENS THE SHEATH LEAK AROUND THE HUB AND THERE IS A VERY LARGE CHANCE THE PIECE COULD BE LEFT IN THE PATIENT'S BODY; HOWEVER, LUCKILY THIS DIDN'T OCCUR. 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
    363123 DESILETS-HOFFMAN SHEATH INTRODUCER DYB INTRODUCER, CATHETER DYB COOK, INC. NA 4484431

    Patients

    Seq Age Sex Outcome Treatment
    1