BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTPORT VENT CATHETER

    MDR report key: 1012875 · Received March 12, 2008

    Report

    Report Number
    2210968-2008-00152
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    DWF
    PMA / PMN Number
    K981009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE RETURN OF THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. FURTHER INFO RECEIVED OR DERIVED FROM THE EVAL WILL BE PROVIDED WITH A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF TWO MEDWATCH REPORTS BEING SUBMITTED AS TWO SEPARATE DEVICES WERE USED. SEE 2210968-2008-00153 FOR THE OTHER MEDWATCH. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, THE DR COULD NOT GET THE CATHETER TO GO THROUGH THE INTRODUCER. A SECOND CATHETER WAS OPENED AND ATTEMPTED WITH THE SAME RESULTS. THE DR THEN OPENED A THIRD CATHETER, AND IT WENT THROUGH THE INTRODUCER SUCCESSFULLY. THE CASE WAS THEN COMPLETED AND THERE WERE NO ADVERSE PT CONSEQUENCES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTPORT VENT CATHETER CATHETER DWF ETHICON, INC. NA MS1007019

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR