BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 3955176 · Received July 18, 2014

    Report

    Report Number
    2020394-2014-00332
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072283
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE MANUFACTURING REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE BALLOON RUPTURE LIKELY CAUSED THE RETRACTION DIFFICULTIES AND THE RETRACTION DIFFICULTIES LIKELY CONTRIBUTED TO THE BALLOON DETACHMENT. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE BALLOON RUPTURE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED (ATM UNKNOWN) DURING THE FIRST INFLATION IN THE SFA. DURING RETRACTION OF THE CATHETER THROUGH THE INTRODUCER SHEATH, THE BALLOON DETACHED FROM THE CATHETER SHAFT. A CUTDOWN WAS PERFORMED TO REMOVE THE DETACHED BALLOON FROM THE VESSEL. THERE WERE NO REPORTED CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423368 DORADO PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93BY0217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention