BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 1032285 · Received April 21, 2008

    Report

    Report Number
    2020394-2008-00097
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K014212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. UPON INSPECTION OF THE RETURNED SAMPLE, THE SHAFT OF THE CATHETER APPEARED INTACT UP TO THE POINT JUST PROXIMAL OF THE PROXIMAL BOND. THE OUTER SHAFT WAS ALMOST COMPLETELY CIRCUMFERENTIALLY SEPARATED. IT IS IMPOSSIBLE TO DETERMINE THE EXACT FAILURE MODE, BUT THIS APPEARED TO BE A JAGGED SEPARATION. THE INNER SHAFT (POLYIMIDE) UNDERNEATH THE OUTER SHAFT SEPARATION WAS SEVERELY KINKED. IT COULD NOT BE DETERMINED IF THIS KINK CONTRIBUTED TO THE SHAFT SEPARATION. DUE TO THE CONDITION OF THE SAMPLE AS RETURNED, FURTHER EVALUATION WAS NOT POSSIBLE. THE RESULT OF THE INVESTIGATION WAS CONFIRMED FOR A SHAFT BREAK, ROOT CAUSE UNKNOWN. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTA PROCEDURE FOR VENOUS STENOSIS OF A LEFT AV GRAFT, IT WAS NOTED THAT THERE WAS A BOND LEAK. A 6F SHORT SHEATH AND A 0.035 GUIDEWIRE WERE USED FOR THE PROCEDURE. THE BALLOON NEVER INFLATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PTA BALLOON. NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFRL1252

    Patients

    Seq Age Sex Outcome Treatment
    1