BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTPORT VENT CATHETER

    MDR report key: 1024205 · Received March 27, 2008

    Report

    Report Number
    2210968-2008-00187
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    DWF
    PMA / PMN Number
    K981009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 REC'D OR DERIVED FROM THE EVALUATION WILL BE PROVIDED WITH A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT THE CATHETER WOULD NOT GO THROUGH THE INTRODUCER. DURING THE INSERTION ATTEMPTS THE CATHETER TIP BECAME DAMAGED AND BROKE. THIS OCCURRED OUTSIDE OF THE BODY AND THERE WERE NO ADVERSE PT CONSEQUENCES AS A RESULT. ANOTHER CATHETER WAS OBTAINED AND USED DURING THE PROCEDURE.

    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 82 YR