BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 1161499 · Received September 15, 2008

    Report

    Report Number
    3004742046-2008-00215
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUSPECTED PINHOLE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY, DURING PRE-DILATION, AS THE BALLOON WAS INFLATED NO CONTRAST ENTERED THE BALLOON. BLOOD ENTERED THE BALLOON WHEN NEGATIVE PRESSURE WAS PULLED. A BALLOON PINHOLE WAS SUSPECTED BUT WAS NOT OBSERVED. THE PROCEDURE WAS COMPLETED WITHOUT LESION PRE-DILATATION. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8012251

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR