BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA AIR BALLOON CATHETER 5X24

    MDR report key: 2514593 · Received March 29, 2012

    Report

    Report Number
    3005172759-2012-00008
    Event Type
    Injury
    Date Received
    March 29, 2012
    Date of Event
    February 27, 2012
    Report Date
    March 1, 2012
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KTI
    PMA / PMN Number
    K110218
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, ACCLARENT BELIEVES THAT THE INSPIRA AIR DEVICE PERFORMED AS INTENDED. THE PHYSICIAN NOTED THAT THE DEVICE PERFORMED AS EXPECTED, WITHOUT ANY PROBLEMS. MUCOSAL TEARS ARE SEEN FOLLOWING USE OF ANY BALLOON FOR DILATION OF THE AIRWAY. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADD'L INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ONE PT. ACCLARENT BECAME AWARE OF THIS EVENT ON (B)(6) 2012. ON (B)(6) 2012, THE PHYSICIAN PERFORMED A DILATION OF THE PT'S STENOSIS USING THE ACCLARENT INSPIRA AIR 5X24 MM BALLOON CATHETER. UPON ENDOSCOPIC INSPECTION OF THE DILATED AREA A SMALL LACERATION OF THE POSTERIOR WALL OF THE TRACHEA WAS VISIBLE. BECAUSE OF THE LOCATION ON THE POSTERIOR WALL OF THE TRACHEA SWALLOWING X-RAY WAS PERFORMED. NO PERFORATION WAS FOUND FROM THE POSTERIOR TRACHEAL WALL INTO THE ESOPHAGUS. THE PT WAS KEPT OVERNIGHT AND DISCHARGED THE FOLLOWING DAY. AS OF (B)(6) 2012, THERE HAVE BEEN NO OTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRA AIR BALLOON CATHETER 5X24 INSPIRA KTI ACCLARENT, INC. NA 110808A

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Hospitalization