BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA INSPIRA AIR 14X40MM BALLOON CATHETER

    MDR report key: 2873585 · Received November 14, 2012

    Report

    Report Number
    3005172759-2012-00034
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ACCLARENT
    Product Code
    KTI
    PMA / PMN Number
    K110218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP WITH THE PHYSICIAN TO GATHER ADD'L INFO. THE SURGEON STATED THAT HE UNDERSTOOD THAT THE USE OF INSPIRA AIR BALLOON WAS OFF LABEL AND HE IS AWARE OF THE RECOMMENDATIONS OF POSITIONING THE BALLOON WITHIN A STENOSIS AND NOT PULLING ON THE SHAFT. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNK. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. .

    Description of Event or Problem · 1

    ACCLARENT BECAME AWARE OF AN EVENT DURING A CONFERENCE ON (B)(6) 2012 INVOLVING AN ACCLARENT INSPIRA AIR BALLOON THAT HAD OCCURRED 2-3 YEARS AGO. THE SURGEON USED THE ACCLARENT INSPIRA AIR 14X40MM BALLOON OFF LABEL TO DILATE THE LARYNGEAL STENOSIS. IT WAS NOTED BY THE PHYSICIAN THAT HE PASSED THE BALLOON DISTALLY WITHIN THE STENOSIS AND DURING THE PROCESS, HE PULLED HARD AGAINST RESISTANCE. THE SURGEON THEN HAD DIFFICULTY TO DEFLATE THE BALLOON AND HAD TO "OVER INFLATED" THE BALLOON CAUSING IT TO RUPTURE SO IT COULD BE REMOVED. THERE WAS NO TRAUMA TO THE AIRWAY AND NO INJURY TO THE PT. A SECOND 14C40MM INSPIRA AIR BALLOON WAS USED BY THE PHYSICIAN AND THE AIRWAY SUCCESSFULLY DILATED. THERE WAS NO PT INJURY AND NO ADD'L MEDICAL CARE OR INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA INSPIRA AIR 14X40MM BALLOON CATHETER INSPIRA AIR KTI ACCLARENT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK