BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTPORT VENT CATHETER

    MDR report key: 1020743 · Received March 27, 2008

    Report

    Report Number
    2210968-2008-00191
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/27/2008. CONCLUSION: THE RETURN OF THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. FURTHER INFORMATION RECEIVED 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 DOCTOR ENCOUNTERED DIFFICULTY PLACING THE CATHETER. THE CATHETER WAS SUCCESSFULLY INSERTED THROUGH THE INTRODUCER, HOWEVER, RESISTANCE WAS FELT ONCE THE CATHETER WAS THROUGH TIP OF THE INTRODUCER. THE CATHETER WOULD NOT ADVANCE MUCH PAST THE TIP OF THE INTRODUCER. AS A RESULT, THE DOCTOR PLACED A NEW INTRODUCER INTO THE PATIENT'S LEFT SUBCLAVIAN AND THEN WAS ABLE TO SUCCESSFULLY PLACE THE CATHETER INTO THE PATIENT. IT WAS FELT THAT EITHER THE TWO INTRODUCERS WERE TOO CLOSE TOGETHER IN THE RIGHT INTERNAL JUGULAR OR THAT THE PATIENT'S VASCULATURE WAS SMALL, IN WHICH THE EV COULD NOT BE FULLY PLACED INTO THE VESSEL WITH THE OTHER CATHETER PRESENT.

    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 Required Intervention