BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACCESS PTA BALLOON DILATION CATHETER

    MDR report key: 3850770 · Received March 20, 2014

    Report

    Report Number
    2020394-2014-00094
    Event Type
    Injury
    Date Received
    March 20, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED AND THEN DETACHED DURING RETRACTION. THE ACCESS SITE WAS SLIGHTLY ENLARGED AND THE DETACHED BALLOON SEGMENT WAS SUCCESSFULLY REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167209 VACCESS PTA BALLOON DILATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93HX0023

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention