BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSPIRA AIR BALLOON DILATION SYSTEM

    MDR report key: 2654323 · Received July 2, 2012

    Report

    Report Number
    3005172759-2012-00020
    Event Type
    Other
    Date Received
    July 2, 2012
    Date of Event
    June 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K110218
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT AND CONTACTED THE REPORTING PHYSICIAN. THE PHYSICIAN REPORTED THAT HE HAS SPECIFICALLY SELECTED A LARGE BALLOON FOR MAXIMAL DILATATION, BUT HAD NOT MEASURED THE PT'S AIRWAY PRIOR TO USING THE BALLOON. THE PT WAS SAID TO HAVE BEEN DISCHARGED THE DAY FOLLOWING THE EVENT. THE DEVICE REFERENCE IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED TEMPORARY MUCOSAL DAMAGE COULD NOT BE DETERMINED. BASED UPON THE INFORMATION PROVIDED, THE EVENT MAY HAVE BEEN RELATED TO TOO LARGE OF A BALLOON BEING USED FOR THE AIRWAY. THIS EVENT WILL BE MONITORED FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ACCLARENT RECEIVED A REPORT THAT THE SUBJECT DEVICE WAS USED IN A PROCEDURE TO EXPAND THE AIRWAY IN A PT WITH MODERATE TO SEVERE ACQUIRED TRACHEAL STENOSIS. THE PHYSICIAN INITIALLY LASERED SEVERAL INCISIONS INTO THE TRACHEAL SCAR AND MUCOUS MEMBRANE OF THE PT'S AIRWAY. THE BALLOON WAS PLACED IN THE AIRWAY AND THE SITE DILATED FOR 1-2 MINUTES. THE PHYSICIAN REPORTED THERE WAS MORE DAMAGE TO THE AIRWAY MUCOSA THAN WHAT HE EXPECTED FOLLOWING DEFLATION. AN X-RAY WAS PERFORMED, AND SHOWED NO FREE AIR IN THE CHEST OR MEDIASTINUM, AND THE PT WAS ADMITTED TO THE USER FACILITY FOR OBSERVATION OVERNIGHT. FOLLOWING THE EVENT THE PT WAS SAID TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRA AIR BALLOON DILATION SYSTEM AIRWAY BALLOON CATHETER KAM ACCLARENT, INC. 18X40MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization