BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 3052872 · Received April 11, 2013

    Report

    Report Number
    3005099803-2013-02428
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STUDY SOURCE: POST-FDA APPROVAL CLINICAL TRIAL EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA ((B)(4)).

    Additional Manufacturer Narrative · 1

    (B)(6). STUDY (B)(4): EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA (B)(4). 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 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 CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2013 AS PART OF THE (B)(4) STUDY. THIS REPORT IS BEING SUBMITTED BASED ON THE EVENT OF PNEUMONIA TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS SECOND BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT LOWER LOBE ON (B)(6) 2013. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON (B)(6) 2013, THE PATIENT DEVELOPED LETHARGY AND CHEST BURN. NO INTERVENTION WAS PERFORMED TO TREAT THE LETHARGY. HOWEVER, AZITHROMYCIN WAS PROPHYLACTICALLY PRESCRIBED FOR THE PATIENT'S CHEST BURN. THE EVENTS RESOLVED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EVENT OF PNEUMONIA. THE PATIENT COMPLAINED OF SHORTNESS OF BREATH AND FEVER, AND WAS TREATED WITH TYLENOL AND MOXIFLOXACIN. ON (B)(6) 2013, THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO FEVER. ON (B)(6) 2013, HE WAS DISCHARGED. ON (B)(6) 2013, THE EVENT OF PNEUMONIA WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES - VISIT DATE: (B)(6) 2013: PRE-BRONCHODILATOR: FEV1: 3.59, FEV1 % PREDICTED: 91.58, FVC: 5.39, FVC % PREDICTED: 103.06. POST-BRONCHODILATOR: FEV1: 3.79, FEV1 % PREDICTED: 96.68, FVC: 5.91, FVC % PREDICTED: 113.00.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2013 AS PART OF THE (B)(4) CLINICAL STUDY. THIS REPORT IS BEING SUBMITTED BASED ON THE EVENT OF PNEUMONIA TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS SECOND BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT LOWER LOBE ON MARCH 13, 2013. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. ON MARCH 14, 2013, THE PATIENT DEVELOPED LETHARGY AND CHEST BURN. NO INTERVENTION WAS PERFORMED TO TREAT THE LETHARGY. HOWEVER, AZITHROMYCIN WAS PROPHYLACTICALLY PRESCRIBED FOR THE PATIENT¿S CHEST BURN. THE EVENTS RESOLVED ON MARCH 19, 2013. ON MARCH 19, 2013, THE PATIENT EXPERIENCED AN EVENT OF PNEUMONIA. THE PATIENT COMPLAINED OF SHORTNESS OF BREATH AND FEVER, AND WAS TREATED WITH TYLENOL AND MOXIFLOXACIN. ON MARCH 22, 2013, THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO FEVER. ON MARCH 25, 2013, HE WAS DISCHARGED. ON MARCH 30, 2013, THE EVENT OF PNEUMONIA WAS CONSIDERED TO BE RESOLVED. BASELINE SPIROMETRY VALUES - VISIT DATE: FEBRUARY 12, 2013 PRE-BRONCHODILATOR FEV1: 3.59 FEV1 % PREDICTED: 91.58 FVC: 5.39 FVC % PREDICTED: 103.06 POST-BRONCHODILATOR FEV1: 3.79 FEV1 % PREDICTED: 96.68 FVC: 5.91 FVC % PREDICTED: 113.00 **ADDITIONAL INFORMATION RECEIVED AS OF OCTOBER 4, 2013** ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED THE EVENT OF PNEUMONIA ON MARCH 14, 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154527 BRONCHIAL THERMOPLASTY CATHETER BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention