BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 2962985 · Received February 15, 2013

    Report

    Report Number
    3005099803-2013-00874
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE FIRST ELECTRODE OF THE ARRAY WAS BENT. IN ADDITION, THE PROXIMAL SHAFT WAS FOUND TO BE BENT AT APPROXIMATELY 19.0" WHEN MEASURED FROM THE DISTAL TIP OF THE CATHETER. NO OTHER ISSUES WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL SPECIFICATION REQUIREMENTS, ALLOWING IT TO BE RELEASED FOR DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER SIMILAR COMPLAINTS EXIST FOR THE REPORTED BATCH NUMBER. A LABELING REVIEW WAS PERFORMED AND IT WAS NOTED THAT ASTHMA EXACERBATION AND UPPER RESPIRATORY TRACT INFECTION ARE LISTED IN THE DIRECTIONS FOR USE (DFU) AS POSSIBLE ADVERSE EVENTS THAT MAY OCCUR. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION. (B)(4): OPERATIONAL PROBLEM IS BEING USED TO CAPTURE THE BENT ARRAY AND BENT CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4). STUDY SOURCE: POST-FDA APPROVAL CLINICAL TRIAL EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA (PAS2).

    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)(6). THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT AND RIGHT UPPER LOBES ON (B)(6) 2013. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE ARRAY WAS INVERTED. THE PROCEDURE WAS COMPLETED WITH A SECOND ALAIR CATHETER. FOLLOWING THE PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED EXACERBATION OF HIS ASTHMA SYMPTOMS. TWO DAYS LATER, THE PATIENT REPORTED FEELING BETTER AND THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. NO MEDICAL INTERVENTION WAS REQUIRED. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED FOR THIS EVENT. ON (B)(6) 2013, THE PATIENT DEVELOPED AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH SYMPTOMS OF INCREASED WHEEZING AND COUGH WITH GREEN MUCOUS PRODUCTION. ON (B)(6) 2013, THE PATIENT VISITED HER PRIMARY CARE PHYSICIAN (PCP) AND WAS PRESCRIBED AUGMENTIN. THE PATIENT BEGAN TAKING THE ANTIBIOTIC ON (B)(6) 2013 FOR SEVEN DAYS. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. THE EVENT IS REPORTED AS NOT RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR: FEV1: 3.06, FEV1 % PREDICTED: 96.84, FVC: 3.76, FVC % PREDICTED: 97.16. POST-BRONCHODILATOR: FEV1: 3.17, FEV1 % PREDICTED: 100.32, FVC: 3.82, FVC % PREDICTED: 98.71.

    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 COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT AND RIGHT UPPER LOBES ON (B)(6) 2013. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE ARRAY WAS INVERTED. THE PROCEDURE WAS COMPLETED WITH A SECOND ALAIR CATHETER. FOLLOWING THE PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED EXACERBATION OF HIS ASTHMA SYMPTOMS. TWO DAYS LATER, THE PATIENT REPORTED FEELING BETTER AND THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. NO MEDICAL INTERVENTION WAS REQUIRED. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED FOR THIS EVENT. ON (B)(6) 2013, THE PATIENT DEVELOPED AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH SYMPTOMS OF INCREASED WHEEZING AND COUGH WITH GREEN MUCOUS PRODUCTION. ON (B)(6) 2013, THE PATIENT VISITED HER PRIMARY CARE PHYSICIAN (PCP) AND WAS PRESCRIBED AUGMENTIN. THE PATIENT BEGAN TAKING THE ANTIBIOTIC ON (B)(6) 2013 FOR SEVEN DAYS. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. THE EVENT IS REPORTED AS NOT RESOLVED. **ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2013** ON (B)(6) 2013, THE PATIENT DEVELOPED AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH SYMPTOMS OF INCREASED WHEEZING AND COUGH WITH GREEN MUCOUS PRODUCTION. ON (B)(6) 2013, PREDNISONE WAS ADDED TO THE PATIENT'S TREATMENT. ON (B)(6) 2013, THE EVENT OF URTI WAS CONSIDERED TO BE RESOLVED.

    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 POST APPROVAL 2 (PAS2) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE LEFT AND RIGHT UPPER LOBES ON (B)(6) 2013. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE ARRAY WAS INVERTED. THE PROCEDURE WAS COMPLETED WITH A SECOND ALAIR CATHETER. FOLLOWING THE PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED EXACERBATION OF HIS ASTHMA SYMPTOMS. TWO DAYS LATER, THE PATIENT REPORTED FEELING BETTER AND THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. NO MEDICAL INTERVENTION WAS REQUIRED. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED FOR THIS EVENT. ON (B)(6) 2013, THE PATIENT DEVELOPED AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH SYMPTOMS OF INCREASED WHEEZING AND COUGH WITH GREEN MUCOUS PRODUCTION. ON (B)(6) 2013, THE PATIENT VISITED HER PRIMARY CARE PHYSICIAN (PCP) AND WAS PRESCRIBED AUGMENTIN. THE PATIENT BEGAN TAKING THE ANTIBIOTIC ON (B)(6) 2013 FOR SEVEN DAYS. NO HOSPITALIZATIONS OR EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. THE EVENT IS REPORTED AS NOT RESOLVED. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2013: ON (B)(6) 2013, THE PATIENT DEVELOPED AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH SYMPTOMS OF INCREASED WHEEZING AND COUGH WITH GREEN MUCOUS PRODUCTION. ON (B)(6) 2013, PREDNISONE WAS ADDED TO THE PATIENT'S TREATMENT. ON (B)(6) 2013, THE EVENT OF URTI WAS CONSIDERED TO BE RESOLVED. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2014: ACCORDING TO THE COMPLAINANT, ONE OF THE SYMPTOMS (MILD ATELECTASIS) OF THE URTI DID NOT STOP UNTIL (B)(6) 2013. THE PATIENT WAS TREATED WITH PREDNISONE TAPER; THEREFORE, THE URTI WAS CONSIDERED RESOLVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68190 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 CM-101712-006

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention