BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 724528 · Received June 9, 2006

    Report

    Report Number
    3004742046-2006-00262
    Event Type
    Injury
    Date Received
    June 9, 2006
    Report Date
    May 12, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    DQY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT AND DEVICE CODES IN H10 WERE CODED BY THE MANUFACTURER. INTERNAL FILE NUMBER - 82170/1

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS: NONE. IT WAS REPORTED THAT DURING A BALLOON DILATATION OF A DIALYSIS GRAFT THE BALLOON RUPTURED WHILE AT OR NEAR NOMINAL PRESSURE. IT WAS NOTED THAT THE RUPTURE WAS IN A CIRCUMFERENTIAL DIRECTION ( THE EXACT PRESSURE WAS NOT KNOWN/REPORTED). THE BALLOON SEPARATED BUT IT WAS SUCCESSFULLY SNARED AND REMOVED. THERE WAS NO REPORTED INJURY AND NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .035 PERIPHERAL DILATATION CATHETER PERIPHERAL DILATATION CATHETER DQY GUIDANT ENDOVASCULAR SOLUTIONS NA 6030251

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention