BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 3201849 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-06121
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ((B)(4)).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). (B)(4). (B)(4). STUDY SOURCE: POST-FDA APPROVAL CLINICAL TRIAL EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA ((B)(6)). 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 BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2013 AS PART OF THE (B)(4) CLINICAL STUDY. 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. FOLLOWING THE PROCEDURE, ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EXACERBATION OF HIS ASTHMA WITH SYMPTOMS INCLUDING INCREASED WHEEZINESS, INCREASED SHORTNESS OF BREATH, BLOOD-TINGED SPUTUM, AND A FEELING OF BODY TEMPERATURE CHANGE. THE EVENT WAS TREATED WITH PREDNISONE, METHYLPREDNISONE, Z-PAK AND TYLENOL. ON (B)(6) 2013, THE PATIENT ALSO EXPERIENCED ATELECTASIS. ON (B)(6) 2013, THE PATIENT COUGHED UP APPROXIMATELY 1-2 CUPS OF BLOOD AND WENT TO THE EMERGENCY ROOM. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND A CT SCAN SHOWED A LEFT LOWER LOBE ABSCESS. THE PATIENT WAS TREATED WITH STEROIDS AND IV ANTIBIOTICS. THE PATIENT'S HEMOPTYSIS HAS IMPROVED BUT IS STILL PRESENT IN SMALL AMOUNTS. THE PATIENT REMAINS HOSPITALIZED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2013. PRE-BRONCHODILATOR - FEV1: 3.29; FEV1 % PREDICTED: 78.15; FVC: 4.79; FVC % PREDICTED: 90.38. POST-BRONCHODILATOR - FEV1: 4.05; FEV1 % PREDICTED: 96.20; FVC: 5.26; FVC % PREDICTED: 99.25. **ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2013** ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE PATIENT HAD NO SIGNS OF INFECTION. A BIOPSY SITE IN THE LEFT LUNG AND THE PREVIOUSLY TREATED RIGHT LOWER LOBE FROM THE FIRST BT TREATMENT APPEARED NORMAL. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD "LONG AIRWAYS AND RECEIVED A HIGH NUMBER OF ACTIVATIONS BUT NOTHING OUT OF THE ORDINARY." IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT LIKELY DEVELOPED MUCOUS PLUGGING AND ATELECTASIS FOLLOWING THE PROCEDURE. THEREFORE, THE PATIENT WAS UNABLE TO CLEAR ACCUMULATED SECRETIONS, THEREBY LEADING TO POST-OBSTRUCTIVE PNEUMONIA WITH EDEMA/INFLAMMATION AND AN ABSCESS. ACCORDING TO THE TREATING PHYSICIAN DURING THE PATIENT'S HOSPITALIZATION, THE PATIENT'S HEMOPTYSIS RESOLVED "SPONTANEOUSLY WITH ANTIBIOTICS." THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WILL CONTINUE WITH ANTIBIOTICS.

    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) 2013 AS PART OF THE POST APPROVAL 2 ((B)(6)) CLINICAL STUDY. 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. FOLLOWING THE PROCEDURE, ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EXACERBATION OF HIS ASTHMA WITH SYMPTOMS INCLUDING INCREASED WHEEZINESS, INCREASED SHORTNESS OF BREATH, BLOOD-TINGED SPUTUM, AND A FEELING OF BODY TEMPERATURE CHANGE. THE EVENT WAS TREATED WITH PREDNISONE, METHYLPREDNISONE, Z-PAK AND TYLENOL. ON (B)(6) 2013, THE PATIENT ALSO EXPERIENCED ATELECTASIS. ON (B)(6) 2013, THE PATIENT COUGHED UP APPROXIMATELY 1-2 CUPS OF BLOOD AND WENT TO THE EMERGENCY ROOM. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND A CT SCAN SHOWED A LEFT LOWER LOBE ABSCESS. THE PATIENT WAS TREATED WITH STEROIDS AND IV ANTIBIOTICS. THE PATIENT'S HEMOPTYSIS HAS IMPROVED BUT IS STILL PRESENT IN SMALL AMOUNTS. THE PATIENT REMAINS HOSPITALIZED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2013. PRE-BRONCHODILATOR: FEV1: 3.29, FEV1 % PREDICTED: 78.15, FVC: 4.79, FVC % PREDICTED: 90.38. POST-BRONCHODILATOR: FEV1: 4.05, FEV1 % PREDICTED: 96.20, FVC: 5.26, FVC % PREDICTED: 99.25.

    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) 2013 AS PART OF THE (B)(4) STUDY. 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. FOLLOWING THE PROCEDURE, ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EXACERBATION OF HIS ASTHMA WITH SYMPTOMS INCLUDING INCREASED WHEEZINESS, INCREASED SHORTNESS OF BREATH, BLOOD-TINGED SPUTUM, AND A FEELING OF BODY TEMPERATURE CHANGE. THE EVENT WAS TREATED WITH PREDNISONE, METHYLPREDNISONE, Z-PAK AND TYLENOL. ON (B)(6) 2013, THE PATIENT ALSO EXPERIENCED ATELECTASIS. ON (B)(6) 2013, THE PATIENT COUGHED UP APPROXIMATELY 1-2 CUPS OF BLOOD AND WENT TO THE EMERGENCY ROOM. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND A CT SCAN SHOWED A LEFT LOWER LOBE ABSCESS. THE PATIENT WAS TREATED WITH STEROIDS AND IV ANTIBIOTICS. THE PATIENT'S HEMOPTYSIS HAS IMPROVED BUT IS STILL PRESENT IN SMALL AMOUNTS. THE PATIENT REMAINS HOSPITALIZED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2013. PRE-BRONCHODILATOR - FEV1: 3.29; FEV1 % PREDICTED: 78.15; FVC: 4.79; FVC % PREDICTED: 90.38. POST-BRONCHODILATOR - FEV1: 4.05; FEV1 % PREDICTED: 96.20; FVC: 5.26; FVC % PREDICTED: 99.25. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2013. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE PATIENT HAD NO SIGNS OF INFECTION. A BIOPSY SITE IN THE LEFT LUNG AND THE PREVIOUSLY TREATED RIGHT LOWER LOBE FROM THE FIRST BT TREATMENT APPEARED NORMAL. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD "LONG AIRWAYS AND RECEIVED A HIGH NUMBER OF ACTIVATIONS BUT NOTHING OUT OF THE ORDINARY." IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT LIKELY DEVELOPED MUCOUS PLUGGING AND ATELECTASIS FOLLOWING THE PROCEDURE. THEREFORE, THE PATIENT WAS UNABLE TO CLEAR ACCUMULATED SECRETIONS, THEREBY LEADING TO POST-OBSTRUCTIVE PNEUMONIA WITH EDEMA/INFLAMMATION AND AN ABSCESS. ACCORDING TO THE TREATING PHYSICIAN DURING THE PATIENT'S HOSPITALIZATION, THE PATIENT'S HEMOPTYSIS RESOLVED "SPONTANEOUSLY WITH ANTIBIOTICS". THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WILL CONTINUE WITH ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2013. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THE PRODUCTIVE COUGH WAS CONSIDERED RESOLVED AS OF (B)(6) 2013, THE LOWER LOBE ABSCESS WAS CONSIDERED RESOLVED AS OF (B)(6) 2013, AND THE EXACERBATION OF ASTHMA WAS CONSIDERED RESOLVED AS OF (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301151 BRONCHIAL THERMOPLASTY CATHETER BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010 CM-081012-037

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R