BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYPERFORM 7X7MM

    MDR report key: 612899 · Received June 10, 2005

    Report

    Report Number
    2029214-2005-00038
    Event Type
    Other
    Date Received
    June 10, 2005
    Date of Event
    May 25, 2005
    Report Date
    June 10, 2005
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, AFTER EMBOLIZATION OF LT. VA-PICA ANEURYSM SUCCESSFULLY BY SL 10 MICRO CATHETER WITH 3 GDC COILS (5X8, 4X6, 2X3), THE ASSISTED HYPERFORM OCCLUSION BALLOON CATHETER CAME OUT ALONG WITH LT. VA UNDER FLUOROSCOPY. THE HYPERFORM BALLOON WAS INFLATED AND DEFLATED IN EVERY DEPLOYING GDC BY AROUND 0.2-0.25 CC INFLATION VOLUME. THE BLOOD FLOW LOOKED STABLE AT THIS STEP. THEN PHYSICIAN TRIED TO DEFLATE HYPERFORM BALLOON. THE BLOOD PRESSURE ROSE. THE PHYSICIAN FEARED SAH AND DECIDED TO SACRIFICE PT LT. VA. AND DEPLOYED COILS FROM RT. VA (TOTAL 13 TRUFILL AND GDC COILS) AT DISTAL PORTION OF AN. THE PT SHOWED STABLE VITAL SIGNS AT THIS TIME. THEN THE PHYSICIAN INSERTED HYPERFORM 4X7 AT PROXIMAL VA AND REMOVED HYPERFORM 7X7 . THE BLOOD PRESSURE DECREASED. THEN PHYSICIAN DEPLOYED ADDITIONALLY 2 COILS AT LT. VA-PICA AREA AND EXPECTING COMPLETED OCCLUSION OF LT. VA. AFTER ALL, PHYSICIAN CONFIRMED LT. VA OCCLUSION BY FLUSHING CONTRAST, AND ALSO RT. VA SHOWED NO BLOOD FLOW. AFTER 5 MINUTES, INTERVAL RT. VA DID NOT RECOVER BLOOD FLOW. ANGIOGRAPHY FROM RT. VA DID NOT RECOVER BLOOD FLOW. ANGIOGRAPHY FROM RT. IC SHOWED NO BLOOD FLOW. ANGIOGRAPHY FROM RT. IC SHOWED NO BLOOD FLOW. CT IMAGE CONFIRMED SAH. THE PHYSICIAN IS NOT THINKING THERE WERE ANY DEFECTS IN USED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM 7X7MM OCCLUSION BALLOON CATHETER MJN MICRO THERAPEUTICS, INC. 104-4770 672889

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other