BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCEPTER OCCLUSION BALLOON CATHETER

    MDR report key: 3111188 · Received May 8, 2013

    Report

    Report Number
    2032493-2013-00024
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THE MOST DISTAL 6 CM SEGMENT REMOVED FROM THE DEVICE. THIS IS THE PORTION OF THE DEVICE THAT BECAME ENTRAPPED BY THE EMBOLIC AGENT DURING THE PROCEDURE. THE REMAINDER OF THE DEVICE IS NORMAL IN APPEARANCE. IN A DISCUSSION BETWEEN OUR REPRESENTATIVE AND THE PHYSICIAN, IT WAS INDICATED THAT CATHETER ENTRAPMENT IS AN ANTICIPATED RISK DURING THIS TYPE OF PROCEDURE AND THAT THE BALLOON DID NOT ATTRIBUTE TO THE ENTRAPMENT DURING THIS CASE. WE ARE REPORTING THIS EVENT AS AN ADVERSE EVENT OCCURRED. HOWEVER, THE DEVICE WAS NOT THE CAUSE. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TREATING AN AVM THROUGH VERY TORTUOUS ANATOMY, ONYX WAS INJECTED THROUGH THE BALLOON CATHETER LUMEN. THE BALLOON BECAME ENTRAPPED ON WITHDRAWAL. AS THE DEVICE WAS WITHDRAWN, IT STRETCHED AND BROKE LEAVING APPROXIMATELY 6 CM IN THE AVM AREA. A STENT WAS PLACED TO SECURE THE STRETCHED SEGMENT TO THE VESSEL WALL. NO HARM WAS REPORTED. THE PT WILL CONTINUE TO BE TREATED TO EMBOLIZE THE AVM IN STAGES AND THIS AREA WILL CONTINUE TO BE TREATED WITH ONYX. PT INFORMATION- PT IDENTIFIER, AGE, SEX AND WEIGHT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200190 SCEPTER OCCLUSION BALLOON CATHETER BALLOON CATHETER MJN MICROVENTION, INC. BC410C 13020644

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention