BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 1772215 · Received July 22, 2010

    Report

    Report Number
    3004742046-2010-00328
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    April 30, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RECOIL AND DISSECTION REQUIRING INTERVENTION. TIME OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT AFTER DILATATION OF THE VERTEBRAL BRANCH OF THE SUBCLAVIAN ARTERY USING A VIATRAC BALLOON,THE TARGET VESSEL RECOILED AND DISSECTED REQUIRING AN UNSPECIFIED ABBOTT STENT TO SEAL THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADDITIONAL INFORMATION 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention NAV6 EMBOSHIELD 2.5 (PART 22437-19)| STENT: ABBOTT 5.0 X 12| EMBOLIC PROTECTION:| VESSEL CLOSURE: PERCLOSE