BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 862128 · Received June 5, 2007

    Report

    Report Number
    9615728-2007-00001
    Event Type
    Injury
    Date Received
    June 5, 2007
    Date of Event
    May 3, 2007
    Report Date
    May 23, 2007
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    HCG
    PMA / PMN Number
    K991549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO PRODUCT LABELING, EMBOSPHERE MICROSPHERES ARE INDICATED FOR USE IN EMBOLIZATION OF ARTERIOVENOUS MALFORMATIONS, HYPERVASCULAR TUMORS AND SYMPTOMATIC UTERINE FIBROIDS. EMBOSPHERE MICROSPHERES ARE NOT INDICATED FOR HEMOSTASIS. USE OF EMBOSPHERE MICROSPHERES FOR EMBOLIZATION RELATED TO EPISTAXIS REPRESENTS OFF-LABEL USE OF THE DEVICE. NO DEVICE MALFUNCTION WAS REPORTED BY TREATING PHYSICIAN. BIOSPHERE MEDICAL DOES NOT HAVE AN EVIDENCE OF PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    BIOSPHERE MEDICAL, INC RECEIVED PHONE CALL WITH THE FOLLOWING INFORMATION: THE PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE WITH EMBOSPHERE MICROSPHERES TO TREAT THE NOSEBLEED AND BECAME BLIND, SHORTLY AFTER THE PROCEDURE. THE INITIAL CALLER IDENTIFIED HIMSELF AS PATIENT'S BROTHER. TREATING PHYSICIAN WAS CONTACTED 5/7/2007 AND VERBALLY PROVIDED THE FOLLOWING INFORMATION: PATIENT WAS TREATED AT HOSPITAL BY INTERVENTIONAL RADIOLOGIST WITH BIOSPHERE MEDICAL EMBOSPHERE MICROSPHERES 300 - 500 UM. TREATING PHYSICIAN PERFORMED BILATERAL EMBOLIZATION OF THE SPHENOPALITINE ARTERIES. THE TREATMENT WAS PERFORMED DUE TO EPISTAXIS. SHORTLY AFTER THE TREATMENT, THE PATIENT BECAME BLIND AND WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSPHERE MICROSPHERES INTRAVASCULAR EMBOLIZATION DEVICE HCG BIOSPHERE MEDICAL, S.A. S420GH NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R