BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA BALLOON

    MDR report key: 3041993 · Received April 2, 2013

    Report

    Report Number
    3005172759-2013-00014
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTHOR OF THE ARTICLE HAS BEEN CONTACTED BY VP OF MEDICAL AFFAIRS BY PHONE ON (B)(6)2013. THE SURGEON STATED THAT THE LOCATION OF THE HEMATOMA IN THE SUPERIOR ORBITAL SUBMUCOSAL SPACER WAS EVIDENCE OF TRAUMA FROM THE BALLOON USED IN THE FRONTAL SINUS. ACCLARENT ETHMOID SPACER COULD NOT CONTRIBUTE TO THE EVENT SINCE THE SPACER WAS SIGNIFICANT DISTANCE AWAY FROM THE REGION OF THE HEMATOMA. THE SURGEON STATED THAT NO TREATMENT OR INTERVENTION AND THE EYE PROBLEM RESOLVED WITH NO SEQUELAE. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS MADE AWARE OF THIS EVENT ON (B)(6) 2013 WHEN A LITERATURE SEARCH WAS BEING CONDUCTED BY AN ACCLARENT EMPLOYEE. IN THE ARTICLE, AN ACCLARENT BALLOON SINUPLASTY WAS PERFORMED AND AN ACCLARENT ETHMOID SPACER WAS INSERTED. A SUBPERIOSTEAL HEMATOMA DEVELOPED IN THE ROOF OF THE ORBIT RESULTING IN TEMPORARY DIPLOPIA. THE HEMATOMA WAS LOCATED ONLY IN THE SUBPERIOSTEAL SPACE AT THE ROOF OF ORBIT. THE AUTHORS POSTULATE THAT THE UNUSUAL PERFORATIONS IN THE ANTERIOR ORBITAL ROOF BECAME SHEARED FROM THE PRESSURE OF THE BSP BALLOON TRANSMITTED THROUGH OSTEONEOGENIC THICKENED BONE. THE AUTHORS STATE THAT SUBPERIOSTEAL HEMATOMA ARE UNUSUAL AND OCCUR WITH MINOR TRAUMA AROUND THE ORBIT. HE ALSO STATED THAT THE LOCATION OF THE HEMATOMA IN THE SUPERIOR ORBITAL SUBMUCOSAL SPACE WAS EVIDENCE OF TRAUMA FROM THE BALLOON USE IN THE FRONTAL SINUS. THE ACCLARENT ETHMOID SPACER COULD NOT CONTRIBUTE TO THE PATHOLOGY SINCE THE SPACER WAS A SIGNIFICANT DISTANCE AWAY FROM THE REGION OF THE HEMATOMA. THE SURGEON STATED THAT THERE WAS NO BREACH IN THE BONE OF THE SINUSES. THERE WAS NO INTERVENTION AND THE EYE PROBLEM RESOLVED WITH WATCHFUL WAITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135048 RELIEVA BALLOON SINUS BALLOON CATHETER KAM ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other ACCLARENT ETHMOID SPACER UNKNOWN