BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL XTREME PTA BALLOON CATHETER

    MDR report key: 2180788 · Received April 28, 2011

    Report

    Report Number
    3004066202-2011-00018
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES, SPA.
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: ROOT CAUSE UNDETERMINED; DEVICE NOT RETURNED, LIMITED INFO AVAILABLE. BALLOON BURST.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO ADVANCE AN ADMIRAL XTREME PTA BALLOON CATHETER TO A SEVERELY CALCIFIED, 100% STENOSED LESION IN THE COMMON ILIAC ARTERY, HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PT AND STORED IN SALINE. ANOTHER PTA BALLOON CATHETER WAS SELECTED AND DILATED THE LESION, HOWEVER, THE PHYSICIAN FELT THAT THE DILATATION WAS NOT SUFFICIENT. THE ADMIRAL XTREME PTA BALLOON CATHETER WAS TAKEN AGAIN AND WAS POSITIONED IN THE LESION. UPON INFLATION, THE BALLOON RUPTURED AT 5 ATM. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER PTA BALLOON CATHETER. THERE WAS NO HEALTH HAZARD CAUSED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMIRAL XTREME PTA BALLOON CATHETER LIT INVATEC INNOVATIVE TECHNOLOGIES, SPA. NA 1B002683

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK