BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 1161510 · Received September 15, 2008

    Report

    Report Number
    3004742046-2008-00216
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 11, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT DEVICE INVESTIGATION, A ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THAT A BALLOON BECAME DAMAGED DURING PRODUCTION OR DURING REMOVAL FROM THE PACKAGING. PRODUCTION INSPECTS 100% VISUALLY FOR BALLOON AND SHAFT DAMAGE. PRODUCTION ALSO PRESSURIZES THE BALLOONS 100% TO RATED BURST PRESSURE AND PERFORMS A LEAK TEST. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: POSSIBLE BALLOON RUPTURE. TIME OF MALFUNCTION: DURING DEVICE PREPARATION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING DEVICE PREPARATION, WHEN NEGATIVE PRESSURE WAS APPLIED, AIR WAS DRAWING AND IT WAS BELIEVED THAT THERE WAS A HOLE IN THE BALLOON. THE DEVICE WAS USED IN THE BODY AND THERE WAS NO PT INVOLVEMENT. 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 7092551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA