BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3718359 · Received April 1, 2014

    Report

    Report Number
    3005099803-2014-01509
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE 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 BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT WAS DIFFICULT TO SEDATE AND SEEMED TO REACT TO GLYCOPYRROLATE BECAUSE OF OBSERVED TACHYCARDIA DURING PROCEDURE. THE PROCEDURE WAS COMPLETED BY A FIRST YEAR FELLOW WITH LOTS OF COUGHING DURING THE PROCEDURE DUE TO THE DIFFICULTY IN SEDATING. PROCEDURE TOOK 2 HOURS, THERE WAS LOTS OF OOZING OR SMALL AMOUNTS OF BLEEDING. THEY USED EPINEPHRINE TO MINIMIZE THIS DURING THE PROCEDURE. THE PATIENT WAS BEING OBSERVED IN RECOVERY AT KECK HOSPITAL WHEN PHYSICIAN DR. CHANG NOTED THE PATIENT¿S LABORED BREATHING AND ORDERED A CHEST X-RAY. THE X-RAY REVEALED A PNEUMOTHORAX AND THE PATIENT WAS INTUBATED AND A CT SCAN CONFIRMED A PNEUMOTHORAX IN THE LOWER RIGHT LOBE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY, (B)(6) 2014, AND IS ¿DOING FINE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194798 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R