BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTPORT VENT CATHETER

    MDR report key: 1012872 · Received March 12, 2008

    Report

    Report Number
    2210968-2008-00154
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    DWF
    PMA / PMN Number
    K981009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE RETURN OF THE PROD UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. FURTHER INFO RECEIVED OR DERIVED FROM THE EVAL WILL BE PROVIDED WITH A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE, THE CATHETER COULD NOT BE INSERTED THROUGH THE INTRODUCER. ANOTHER CATHETER WAS USED TO COMPLETE THE CASE WITH NO ADVERSE PT CONSEQUENCE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTPORT VENT CATHETER CATHETER DWF ETHICON, INC. NA MS1207028

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK