BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSPHERE

    MDR report key: 299115 · Received October 4, 2000

    Report

    Report Number
    66641-2000-00002
    Event Type
    Injury
    Date Received
    October 4, 2000
    Date of Event
    September 6, 2000
    Report Date
    September 26, 2000
    Manufacturer
    BIOSPHERE MEDICAL S.A.
    Product Code
    DXE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED, DURING PHONE CONVERSATION, ON SEPTEMBER 7, ATTEMPTING TO EMBOLIZE A CRANIAL ATRIO-VENTRICULAR MALFORMATION LOCATED OFF OF THE INTERNAL CAROTID ARTERY. PHYSICIAN USED 500-700 MICRON. EMBOSPHERE MICROSPHERES BUT FOLLOWED WITH PIECES OF SILK SUTURE MATERIAL. CATHETER BECAME CLOGGED AND WAS SUCCESSFULLY OPENED WITH PRESSURE FROM SYRINGE. PHYSICIAN NOTED REFLUX OF CONTRAST (REVERSED FLOW) WHEN THIS HAPPENED. DURING ANGIOGRAPHIC EVALUATION, FOLLOWING EMBOLIZATION, PHYSICIAN NOTED THAT OPTHALMIC ARTERY OCCLUSION. TOTAL PARENTERAL ALIMENTATION INFUSION WAS ATTEMPTED BUT VESSEL SLOW REMAINED SLUGGISH. PT LOST SIGHT IN ONE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSPHERE ARTIFICIAL EMBOLIZATION DEVICE DXE BIOSPHERE MEDICAL S.A. * E123

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention PROWLER 10 MICROCATHETER. SILK SUTURE MATERIAL.