BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 5518963 · Received March 23, 2016

    Report

    Report Number
    3005099803-2016-00672
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    June 22, 2015
    Report Date
    February 26, 2016
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER COULD NOT BE MATCHED TO THE REPORTED DEVICE. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME. STUDY SOURCE: (B)(4) 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.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION.

    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 (B)(4) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ASTHMA EXACERBATION AND WAS TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED. ON (B)(6) 2015 THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2015; PRE-BRONCHODILATOR: FEV1: 2.05; FEV1 % PREDICTED: 72.00; FVC: 3.08; FVC % PREDICTED: 94.00. POST-BRONCHODILATOR: FEV1: 2.71; FEV1 % PREDICTED: 96.00; FVC: 3.54; FVC % PREDICTED: 108.00.

    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 ASTHMA EXACERBATION TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ASTHMA EXACERBATION AND WAS TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED. ON (B)(6) 2015 THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2015. PRE-BRONCHODILATOR: FEV1: 2.05, FEV1 % PREDICTED: 72.00, FVC: 3.08, FVC % PREDICTED: 94.00. POST-BRONCHODILATOR: FEV1: 2.71, FEV1 % PREDICTED: 96.00, FVC: 3.54, FVC % PREDICTED: 108.00.

    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 (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ASTHMA EXACERBATION AND WAS TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED. ON (B)(6) 2015 THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2015, PRE-BRONCHODILATOR, FEV1: 2.05, FEV1 % PREDICTED: 72.00, FVC: 3.08, FVC % PREDICTED: 94.00. POST-BRONCHODILATOR, FEV1: 2.71, FEV1 % PREDICTED: 96.00, FVC: 3.54, FVC % PREDICTED: 108.00. **ADDITIONAL INFORMATION RECEIVED ON 14OCT2016** ON (B)(6) 2015 THE EVENT WAS CONSIDERED TO BE 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 (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ASTHMA EXACERBATION AND WAS TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED. ON (B)(6) 2015 THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES VISIT DATE: (B)(6) 2015, PRE-BRONCHODILATOR, FEV1: 2.05, FEV1 % PREDICTED: 72.00, FVC: 3.08, FVC % PREDICTED: 94.00. POST-BRONCHODILATOR FEV1: 2.71, FEV1 % PREDICTED: 96.00, FVC: 3.54, FVC % PREDICTED: 108.00. ADDITIONAL INFORMATION RECEIVED ON 14OCT2016: ON (B)(6) 2015 THE EVENT WAS CONSIDERED TO BE RESOLVED. ADDITIONAL INFORMATION RECEIVED ON 13DEC2016: THE PATIENT WAS TREATED WITH MOXYFLOXACIN AND ANALGESIC ANTI-INFLAMMATORY FOR THE ASTHMA EXACERBATION. THE ANTIBIOTIC WAS GIVEN PROPHYLACTICALLY.

    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 ASTHMA EXACERBATION TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ASTHMA EXACERBATION AND WAS TREATED WITH MEDICATION (EXACT MEDICATION TYPE NOT REPORTED). NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED. ON (B)(6) 2015 THE EVENT WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE (B)(6) 2015. PRE-BRONCHODILATOR: FEV1 2.05. FEV1 % PREDICTED: 72.00 FVC 3.08. FVC % PREDICTED: 94.00. POST-BRONCHODILATOR: FEV1 2.71. FEV1 % PREDICTED 96.00 FVC 3.54. FVC % PREDICTED 108.00. **ADDITIONAL INFORMATION RECEIVED ON 14OCT2016** ON JULY 3, 2015 THE EVENT WAS CONSIDERED TO BE RESOLVED. **ADDITIONAL INFORMATION RECEIVED ON 13DEC2016** THE PATIENT WAS TREATED WITH MOXYFLOXACIN AND ANALGESIC ANTI-INFLAMMATORY FOR THE ASTHMA EXACERBATION. THE ANTIBIOTIC WAS GIVEN PROPHYLACTICALLY. **ADDITIONAL INFORMATION RECEIVED ON 08FEB2017** THE PATIENT WAS GIVEN ANALGESIC ANTI-INFLAMMATORY TO TREAT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175437 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020 17326483

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention