BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 5305681 · Received December 17, 2015

    Report

    Report Number
    3005099803-2015-03615
    Event Type
    Injury
    Date Received
    December 17, 2015
    Date of Event
    April 10, 2015
    Report Date
    November 20, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE FOR THE BT CATHETER USED DURING THE RESCHEDULED 3RD BT PROCEDURE PERFORMED ON (B)(6) 2015.

    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)(6) STUDY SOURCE: BSC BT REGISTRY CLINICAL STUDY. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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) 2015 AS PART OF THE BSC BT REGISTRY CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF MUCUS PLUGGING REQUIRING HOSPITALIZATION AND MEDICAL TREATMENT. ON (B)(6) 2015, DURING PRE-TREATMENT BRONCHOSCOPIC EXAMINATION OF THE AIRWAYS PRIOR TO THE THIRD BT PROCEDURE, A MUCUS PLUG WAS NOTED IN THE LOWER LEFT LOBE OF THE LUNG. THE PLUG WAS SUCTIONED DURING BRONCHOSCOPY AND THE THIRD BT PROCEDURE WAS POSTPONED. THE PATIENT WAS HOSPITALIZED AND TREATED WITH PREDNISOLONE, AS WELL AS DOXYCYCLINE. BRONCHOALVEOLAR LAVAGE FROM THE LOWER LEFT LOBE WAS WEAKLY POSITIVE ON ASPERGILLUS POLYMERASE CHAIN REACTION (PCR), BUT FUNGAL AND BACTERIAL CULTURES WERE NEGATIVE, SUGGESTING THE MUCUS PLUGGING WAS ASTHMATIC RATHER THAN INFECTIVE. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE. ON (B)(6) 2015, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE EVENT WAS CONSIDERED TO BE RESOLVED. PRE-BRONCHODILATOR: FEV1: 1.78, FEV1 % PREDICTED: 57.00, FVC: 1.99, FVC % PREDICTED: 55.00. **ADDITIONAL INFORMATION RECEIVED ON 26JUL2016** ON (B)(6) 2015 THE PATIENT UNDERWENT THE RESCHEDULED THIRD BRONCHIAL THERMOPLASTY PROCEDURE TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED TO THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2015, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) FOR A LOWER RESPIRATORY TRACT INFECTION (LRTI) AND WAS TREATED WITH PREDNISOLONE. NO HOSPITALIZATIONS OCCURRED. ON (B)(6) 2016 THE LOWER RESPIRATORY TRACT INFECTION HAD RESOLVED.

    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) 2015 AS PART OF THE BSC BT REGISTRY CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF MUCUS PLUGGING REQUIRING HOSPITALIZATION AND MEDICAL TREATMENT. ON (B)(6) 2015, DURING PRE-TREATMENT BRONCHOSCOPIC EXAMINATION OF THE AIRWAYS PRIOR TO THE THIRD BT PROCEDURE, A MUCUS PLUG WAS NOTED IN THE LOWER LEFT LOBE OF THE LUNG. THE PLUG WAS SUCTIONED DURING BRONCHOSCOPY AND THE THIRD BT PROCEDURE WAS POSTPONED. THE PATIENT WAS HOSPITALIZED AND TREATED WITH PREDNISOLONE, AS WELL AS DOXYCYCLINE. BRONCHOALVEOLAR LAVAGE FROM THE LOWER LEFT LOBE WAS WEAKLY POSITIVE ON ASPERGILLUS POLYMERASE CHAIN REACTION (PCR), BUT FUNGAL AND BACTERIAL CULTURES WERE NEGATIVE, SUGGESTING THE MUCUS PLUGGING WAS ASTHMATIC RATHER THAN INFECTIVE. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE. ON (B)(6) 2015, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE EVENT WAS CONSIDERED TO BE RESOLVED. PRE-BRONCHODILATOR: FEV1: 1.78; FEV1 % PREDICTED: 57.00 ; FVC: 1.99; FVC % PREDICTED: 55.00;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834694 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 17834211

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R