BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSPIRA AIR BALLOON CATHETER 10X40MM

    MDR report key: 2063243 · Received April 6, 2011

    Report

    Report Number
    3005172759-2011-00001
    Event Type
    Other
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO FACILITY'S INITIAL REPORT: THE PREVIOUS REPORT FROM THE FACILITY'S RISK MGR STATED THAT THE BALLOON DID NOT OR WAS NOT DEFLATED. UPON F/U WITH THE PHYSICIAN, HE CLARIFIED THAT NO MALFUNCTION OF THE INSPIRA AIR SYSTEM TOOK PLACE. HE NOTED THAT THE DEVICE DID DEFLATE, HOWEVER, THE BRONCHOSCOPE WAS TOO SMALL TO ALLOW THE REMOVAL OF THE BALLOON CATHETER. (INSPIRA AIR WAS USED WITHIN THE WORKING CHANNEL OF THE BRONCHOSCOPE). NOTE, INSPIRA AIR'S IFU WARNINGS AND PRECAUTIONS STATES THE BALLOON DILATION SYSTEM CAN BE USED SIDE BY SIDE WITH A BRONCHOSCOPE. COMPATIBILITY FOR USE WITHIN THE WORKING CHANNEL OF A BRONCHOSCOPE HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    (UPDATED BY ACCLARENT). THIS EVENT OCCURRED IN ONE PT ON (B)(6) 2011. A COPY OF THE FACILITY'S 3500A FORM WAS SENT BY THE FDA TO ACCLARENT, AND WAS RECEIVED BY ACCLARENT'S MGR OF REGULATORY AFFAIRS ON (B)(6) 2011. ACCLARENT'S VP OF MEDICAL AFFAIRS WAS PROMPTLY NOTIFIED, AND GATHERED THE FOLLOWING INFO FROM THE ACTING PHYSICIAN: THE EVENT INVOLVED A 10X40MM INSPIRA AIR DEVICE NOTED TO HAVE A PORTION OF THE BALLOON SEPARATED FROM THE DEVICE UPON REMOVAL THROUGH A BRONCHOSCOPE. THE BRONCHOSCOPE WAS NOTED BY THE PHYSICIAN TO BE TOO SMALL TO ACCOMMODATE THE REMOVAL OF THE BALLOON CATHETER. THE PHYSICIAN NOTED THAT FORCE WAS NEEDED TO REMOVE THE BALLOON AFTER IT EASILY DEFLATED. NOTE, THE PREVIOUS REPORT FROM THE FACILITY'S RISK MGR STATED THAT THE BALLOON DID NOT OR WAS NOT DEFLATED. UPON F/U WITH THE PHYSICIAN, HE CLARIFIED THAT THE INSPIRA AIR DEVICE DID DEFLATE; HOWEVER, THE BRONCHOSCOPE WAS TOO SMALL TO ALLOW THE REMOVAL OF THE BALLOON CATHETER. DUE TO THIS INTERFERENCE, A PORTION OF THE BALLOON TORE AND TEMPORARILY REMAINED IN THE BRONCHUS. THE PORTION OF THE BALLOON WAS PROMPTLY RETRIEVED. THE PHYSICIAN NOTED THAT A SMALL TEAR MAY HAVE BEEN PRESENT IN THE BRONCHUS FROM THE TRAUMA OF REMOVING THE BALLOON. FOR THIS REASON, THE CHILD WAS KEPT OVERNIGHT IN THE INTENSIVE CARE UNIT. THE PT DID WELL AND WAS DISCHARGED WITH NO ILL EFFECTS. THE PHYSICIAN STATED THAT THE RESULT FROM THE INSPIRA AIR DILATIONS ON THE PATIENT WERE EXCELLENT AND NO FURTHER DILATATIONS HAVE BEEN REQUIRED. THE PHYSICIAN DID NOT FEEL THAT THERE WAS A MALFUNCTION OF THE INSPIRA AIR SYSTEM. RATHER, HE FELT THAT THE PROBLEM WAS MERELY A SIZE ISSUE OF TOO LARGE A BALLOON BEING REMOVED THROUGH TOO SMALL A BRONCHOSCOPE. THE PHYSICIAN WAS AWARE THAT THE INSPIRA AIR IS USED FOR DILATION OF THE TRACHEA, AND COMPATIBILITY FOR USE WITHIN THE WORKING CHANNEL OF A BRONCHOSCOPE HAS NOT BEEN ESTABLISHED. IN ADDITION, IT SHOULD BE NOTED THAT ACCLARENT'S IFU STATES TO NEVER ADVANCE OR RETRACT THE DEVICES AGAINST RESISTANCE AS THIS COULD CAUSE TISSUE TRAUMA OR DEVICE DAMAGE. NO DEVICE WAS AVAILABLE FOR EVAL. NO PRODUCT MALFUNCTION WAS NOTED. THE LOT NUMBER PROVIDED WAS REVIEWED, AND WAS FOUND TO MEET SPECIFICATION. NO NEGATIVE TREND HAS BEEN IDENTIFIED WITH THIS COMPLAINT. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADD'L INFO AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRA AIR BALLOON CATHETER 10X40MM INSPIRA AIR KAM ACCLARENT, INC. 10X40MM 100512B

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other PROVIDED BY FACILITY'S INITIAL REPORT: PROCEDURE:| APPLICABLE. OTHER PERTINENT INFO: PT HAS HOME VENT| LEFT BRONCHIAL STENOSIS AND DILATION OF THE| MAIN-STEM BRONCHUS. ETHNIC BACKGROUND: NOT| 4.5 TTS BIVONA TRACH.