BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1070491 · Received July 1, 2008

    Report

    Report Number
    2020394-2008-00183
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RETURNED, AND THE EVAL IS CURRENTLY UNDERWAY. NO REPORTED INJURY TO THE PT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TIPS PROCEDURE, THE DOCTOR REMOVED THE PTA BALLOON AND IT WAS ALLEGED THAT SOME OF THE FIBERS WERE SHREDDED. THE PHYSICIAN WAS DECLOTTING A COVERED STENT AND DID NOT EXCEED THE RBP. HE HAD TO USE ANOTHER PTA BALLOON TO COMPLETE THE PROCEDURE. NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. 93LR0077

    Patients

    Seq Age Sex Outcome Treatment
    1