BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL XTREME PTA BALLOON CATHETER

    MDR report key: 2093371 · Received April 19, 2011

    Report

    Report Number
    3004066202-2011-00016
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 21, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES SPA.
    Product Code
    DQY
    PMA / PMN Number
    K062809
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: RESULTS, CONCLUSION: (LESION MORPHOLOGY). EVAL SUMMARY: A PINHOLE OF 0.3 MM WIDE WAS IDENTIFIED IN THE PROXIMAL PART OF THE BALLOON.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE AN ADMIRAL XTREME PTA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE PERIPHERAL VASCULATURE. HOWEVER, IT WAS REPORTED THAT WHEN THE BALLOON OF THE ADMIRAL XTREME DEVICE WAS INFLATED TO 8 ATMS IT FAILED TO MAINTAIN PRESSURE. UPON REMOVAL FROM THE BODY IT WAS NOTED THAT THE BALLOON HAD A PINHOLE. ANOTHER ADMIRAL XTREME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HEALTH HAZARD WAS CAUSED TO THE PT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMIRAL XTREME PTA BALLOON CATHETER DQY INVATEC INNOVATIVE TECHNOLOGIES SPA. NA 1B014460

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK