BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 1241275 · Received November 21, 2008

    Report

    Report Number
    3004742046-2008-00286
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 30, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE WAS NOT RETURNED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. ALTHOUGH NO PRODUCT MALFUNCTION WAS REPORTED, IT CANNOT BE SAID FOR CERTAIN THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S CONDITIONS. A NEUROLOGICAL EVENT IS A KNOWN PROCEDURAL RISK DURING CAROTID PRE-DILATATION BALLOON INFLATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE. SYMPTOMS/AE: TRANSIENT ISCHEMIC ATTACK. IT WAS REPORTED THAT DURING A RIGHT CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED A TRANSIENT ATTACK AFTER THE INITIAL VIATRAC PRE-DILATATION BALLOON INFLATION. THE PATIENT'S SYMPTOMS CONSISTED OF LEFT FACIAL DROOP, TRANSIENT LARYNGEAL DIFFICULTY AND LEFT ARM NUMBNESS, WHICH WAS TREATED WITH REOPRO, RETAVASE AND HEPARIN. THE SYMPTOMS RESOLVED THE NEXT MORNING, AND THE PATIENT WAS DISCHARGED TO HOME ONE DAY POST PROCEDURE. THOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention RX ACCUNET EPD| RX ACCULINK STENT