BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCEPTER OCCLUSION BALLOON CATHETER

    MDR report key: 2997501 · Received March 5, 2013

    Report

    Report Number
    2032493-2013-00009
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE HAS NOT BEEN PERFORMED AS IT WAS DISCARDED BY THE USER CENTER. THE ROOT CAUSE OF THE INITIAL RESISTANCE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    ON 02/15/2013 MICROVENTION, INC. RECEIVED A MEDWATCH FORM VIA US MAIL. THIS WAS OUR FIRST NOTIFICATION OF A SCEPTER COMPLAINT WHERE DIFFICULTY WAS ENCOUNTERED UPON LOADING COILS. NO HARM WAS REPORTED. OUR SALES REPRESENTATIVE AND FIELD ASSURANCE DEPT. WERE NOT AWARE OF SUCH A COMPLAINT. ON (B)(4) 2013, OUR SALES REPRESENTATIVE VISITED THIS CENTER SPOKE WITH THE IR INVENTORY MANAGER. SHE INDICATED THAT THE INITIAL COIL ENCOUNTERED SOME RESISTANCE DURING A DEPLOYMENT BUT, WAS STILL DEPLOYED WITH ADDITIONAL PRESSURE. THERE WERE THREE SUBSEQUENT COILS DEPLOYED THROUGH THE CATHETER WITHOUT ANY RESISTANCE OR DIFFICULTY. NO HARM OR INJURY WAS ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93845 SCEPTER OCCLUSION BALLOON CATHETER BALLOON CENTER MJN MICROVENTION, INC. BC410C 12051832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other