BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 6233345 · Received January 9, 2017

    Report

    Report Number
    3005099803-2016-04079
    Event Type
    Injury
    Date Received
    January 9, 2017
    Date of Event
    December 13, 2016
    Report Date
    December 13, 2016
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    UDI-DI
    08714729802792
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT WAS NOT REPORTED. HOWEVER; IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18 YEARS OLD. 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 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 PERFORMED ON (B)(6) 2016. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA ATTACK REQUIRING TREATMENT WITH NON-STANDARD MEDICATION (NEOPHYLLINE) AND ADMISSION TO THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2016, THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE. NO ISSUES WERE REPORTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, THE SECOND BT TREATMENT OF THE PATIENT WAS PERFORMED. ¿THE RIGHT LOWER LOBE WHICH WAS TREATED FOR THE FIRST TIME WAS FILLED WITH SPUTUM WITH HIGH CONSISTENCY.¿ THE PHYSICIAN PERFORMED SUCTIONING USING THE PREPARED BF-P290 (SCOPE CHANNEL 2.0MM). HOWEVER, THE SUCTIONING WAS DIFFICULT, SO THE PHYSICIAN CHANGED TO A BF-1 T290 (SCOPE CHANNEL 3.0 MM) AND CONTINUED SUCTIONING THE SPUTUM IN THE LUNG. FOLLOWING THE BRONCHIAL THERMOPLASTY TREATMENT, THE PATIENT EXPERIENCED AN ASTHMA ATTACK WHEN TUBE EXTUBATION WAS PERFORMED. AFTER THE ASTHMA ATTACK, THE PATIENT WAS TREATED WITH HYDROCORTANE (100 MG, STEROID), NEOPHYLLINE (250 MG), AND SOLMETOLOL (250 MG) INTRAVENOUSLY TO RESTORE STABILITY. TREATMENT WAS PERFORMED IN THE OPERATING ROOM FOR ABOUT 15 MINUTES THEN THE PATIENT WAS TAKEN TO THE ICU. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON 11JAN2017. ON (B)(6) 2016 THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY TREATMENT PERFORMED IN THE LEFT LOWER LOBE OF THE LUNGS. DURING THIS PROCEDURE, THE PHYSICIAN ALSO REMOVED SPUTUM FROM THE RIGHT LOWER LOBE OF THE LUNGS. NO DEVICE MALFUNCTION WAS REPORTED AND THE BT CATHETER WAS DISPOSED FOLLOWING THE PROCEDURE. ABOUT TEN MINUTES AFTER THE LAST BT ACTIVATION WAS PERFORMED, BREATHING FUNCTION OF THE PATIENT WAS LOW, SO THE PHYSICIAN ASSUMED THAT A SEVERE ASTHMA EXACERBATION OCCURRED. PER THE PHYSICIAN, THE SEVERE ASTHMA EXACERBATION OCCURRED DUE TO IRRITATION FROM THE EXTUBATION. THE PATIENT'S CURRENT CONDITION IS STABLE AND THE PATIENT WILL UNDERGO THE THIRD BT TREATMENT AFTER A LONGER INTERVAL THAN USUAL.

    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 PERFORMED ON (B)(6) 2016. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA ATTACK REQUIRING TREATMENT WITH NON-STANDARD MEDICATION (NEOPHYLLINE) AND ADMISSION TO THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2016, THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE. NO ISSUES WERE REPORTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, THE SECOND BT TREATMENT OF THE PATIENT WAS PERFORMED. ¿THE RIGHT LOWER LOBE WHICH WAS TREATED FOR THE FIRST TIME WAS FILLED WITH SPUTUM WITH HIGH CONSISTENCY.¿ THE PHYSICIAN PERFORMED SUCTIONING USING THE PREPARED BF-P290 (SCOPE CHANNEL 2.0MM). HOWEVER, THE SUCTIONING WAS DIFFICULT, SO THE PHYSICIAN CHANGED TO A BF-1 T290 (SCOPE CHANNEL 3.0 MM) AND CONTINUED SUCTIONING THE SPUTUM IN THE LUNG. FOLLOWING THE BRONCHIAL THERMOPASTY TREATMENT, THE PATIENT EXPERIENCED AN ASTHMA ATTACK WHEN TUBE EXTUBATION WAS PERFORMED. AFTER THE ASTHMA ATTACK, THE PATIENT WAS TREATED WITH HYDROCORTANE (100 MG, STEROID), NEOPHYLLINE (250 MG), AND SOLMETOLOL (250 MG) INTRAVENOUSLY TO RESTORE STABILITY. TREATMENT WAS PERFORMED IN THE OPERATING ROOM FOR ABOUT 15 MINUTES THEN THE PATIENT WAS TAKEN TO THE ICU. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18674 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 19388833 08714729802792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention