BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL XTREME PTA BALLOON CATHETER OTW 0.035"

    MDR report key: 1972639 · Received January 19, 2011

    Report

    Report Number
    3004066202-2011-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 7, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES, SPA
    Product Code
    DQY
    PMA / PMN Number
    K100921
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS INDICATED THAT THE SUBJECT DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS KNOWN AND A REVIEW OF THE DEVICE HISTORY RECORD WILL BE CONDUCTED. DEVICE DISCARDED - NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE BALLOON DEFLATED UNEXPECTEDLY. THE PHYSICIAN INSERTED THE BALLOON CATHETER INTO THE PT WITH A HIGHLY CALCIFIED LESION. THE PHYSICIAN INFLATED THE BALLOON AND THEN IT SUDDENLY DEFLATED UNEXPECTEDLY. THE DEVICE WAS REMOVED AND REPLACED WITH A SECOND DEVICE AND THE SAME EVENT OCCURRED. NO PT ISSUES. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMIRAL XTREME PTA BALLOON CATHETER OTW 0.035" DQY INVATEC INNOVATIVE TECHNOLOGIES, SPA NA OPIB008831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA