BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIRAL XTREME

    MDR report key: 3052036 · Received April 11, 2013

    Report

    Report Number
    3004066202-2013-00049
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 13, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: NONE ( NO DEVICE RETURNED FOR EVALUATION); NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED; PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (80% STENOSIS AND CALCIFICATION). CONCLUSION: DEVICE FAILURE RELATED TO PATIENT CONDITION (80% STENOSIS AND CALCIFICATION).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION IN THE SFA OF THE LEFT LEG. THE LESION EXHIBITED 80% STENOSIS AND WAS MODERATELY CALCIFIED. IT WAS REPORTED THAT DURING THE POBA PROCEDURE, THE ADMIRAL XTREME BALLOON BURST AFTER BEING INFLATED TO 8 ATMS FOR 2 SECONDS. THIS WAS THE FIRST INFLATION. NO ABNORMALITIES NOTED WITH THE DEVICE DURING PREPARATION. NO RESISTANCE WAS NOTED BETWEEN THE BALLOON AND OTHER DEVICES OR THE LESION DURING THE PROCEDURE. NO FORCE WAS APPLIED DURING DELIVERY OF THE DEVICE THROUGH THE GUIDE CATHETER OR ON THE WIRE TO/ACROSS THE LESION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156747 ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR