BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTPORT VENT CATHETER

    MDR report key: 1012873 · Received March 12, 2008

    Report

    Report Number
    2210968-2008-00155
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Report Date
    February 15, 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 - NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE THAT THE ANESTHESIOLOGIST EXPERIENCED DIFFICULTY INSERTING THE CATHETER INTO THE INTRODUCER. NO FURTHER INFO IS KNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK