BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA SINUS BALLOON CATHETER SYS

    MDR report key: 3889121 · Received June 11, 2014

    Report

    Report Number
    3005172759-2014-00015
    Event Type
    Injury
    Date Received
    June 11, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EVENT DESCRIPTION, THE TREATING PHYSICIAN WAS NOT CERTAIN THAT AN ACCLARENT INSTRUMENT CAUSED THE FRACTURE. ACCLARENT MADE ATTEMPT TWO TIMES TO CONTACT THE TREATING PHYSICIAN TO REQUEST ADDITIONAL INFO BUT DID NOT GET ANY RESPONSES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(6) 2014 OF AN EVENT DURING A SINUS DILATION CASE WHEN ACCLARENT BALLOON DILATION TECH WERE USED. PHYSICIAN REPORTED THAT DURING A RECENT BALLOON SINUPLASTY PROCEDURE, A PT'S LAMINA PAPYRACEA MAY HAVE BEEN FRACTURED UNINTENDEDLY DUE TO BLOOD VISUALIZED IN THE CORNER OF THE PT'S EYE. THE PHYSICIAN IS UNCLEAR IF THE BALLOON OR ACCLARENT'S SINUS GUIDE CATHETER CAUSED THE FRACTURE. THE PT IS FINE AND DID NOT HAVE ANY CONSEQUENCES FROM THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343865 RELIEVA SINUS BALLOON CATHETER SYS SINUS BALLOON CATHETER LRC ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ACCLARENT SINUS GUIDE CATHETER UNK