BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 3092583 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02769
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE VIATRAC PLUS 5 X 15 REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT RENAL ARTERY THAT WAS HEAVILY CALCIFIED. THE 5X15X135 RX VIATRAC PLUS WAS ADVANCED FOR PREDILATATION, WITHOUT RESISTANCE FELT, AND ON THE 2ND INFLATION AT 8 ATMOSPHERES THE BALLOON RUPTURED. THE BALLOON CATHETER WAS RETRACTED WITHOUT ISSUE FROM THE ANATOMY. THE 6X15X135 RX VIATRAC PLUS WAS ADVANCED, AGAIN WITHOUT RESISTANCE, TO COMPLETE PREDILATATION AND ON THE 2ND INFLATION AT 8 ATMOSPHERES THE BALLOON RUPTURED. THE PROCEDURE CONTINUED ON WITHOUT FURTHER DILATATION AND A STENT WAS DEPLOYED SUCCESSFULLY TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194068 RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1