BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2441367 · Received February 7, 2012

    Report

    Report Number
    3005099803-2012-00321
    Event Type
    Injury
    Date Received
    February 7, 2012
    Date of Event
    December 21, 2011
    Report Date
    January 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). STUDY SOURCE: (B)(4) CLINICAL TRIAL EVALUATING (B)(4) IN SEVERE PERSISTENT ASTHMA (PAS2). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2011 AS PART OF THE (B)(4) CLINICAL STUDY. ON (B)(6) 2011, THE PATIENT UNDERWENT THEIR THIRD AND FINAL BRONCHIAL THERMOPLASTY TREATMENT TO THE UPPER RIGHT AND LEFT LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2011, APPROXIMATELY ONE DAY AFTER THE THIRD BRONCHIAL THERMOPLASTY TREATMENT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A SEVERE HEADACHE THAT DID NOT RESOLVE WITH THE USE OF IBUPROFEN. THE SITE REPORTED THAT THE PATIENT HAS A HISTORY OF MIGRAINES. SUBSEQUENTLY, THE PATIENT WAS TREATED INTRAVENOUSLY WITH IMITRIX AND BENADRYL AND WAS DISCHARGED FROM THE EMERGENCY ROOM LATER THAT DAY. NO HOSPITALIZATIONS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2011, THE PATIENT'S HEADACHE RESOLVED. ADDITIONALLY, ON (B)(6) 2011, THE PATIENT EXPERIENCED THE EVENTS OF ABNORMAL CHEST SOUNDS (INCLUDING A BILATERAL UPPER LOBE WHEEZE AND SLIGHT COUGH) AND NECK TENDERNESS. THE PATIENT WAS TREATED MEDICALLY WITH 2.5 MG. OF ALBUTEROL VIA A NEBULIZER FOR THE EVENT OF ABNORMAL CHEST SOUNDS. THE EVENT OF NECK TENDERNESS REQUIRED NO TREATMENT. THESE EVENTS RESOLVED ON (B)(6) 2011. SUBSEQUENTLY, ON (B)(6) 2011, THE PATIENT DEVELOPED A WHEEZE, WHICH WAS TREATED MEDICALLY WITH A TAPERING DOSE OF PREDNISONE. ON (B)(6) 2011, AFTER THE COURSE OF PREDNISONE, THE PATIENT'S WHEEZE RESOLVED. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - MARLBOROUGH M005ATS25010 021010-133

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention