BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2454907 · Received February 16, 2012

    Report

    Report Number
    3005099803-2012-00519
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    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). STUDY SOURCE: (B)(4) EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). PATIENT WEIGHT: (B)(6). STUDY SOURCE: POST-FDA APPROVAL CLINICAL TRIAL EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA (PAS2). 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 THERE IS ANY FURTHER RELEVANT INFORMATION, 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 ON (B)(6) 2012 AS PART OF THE (B)(4). ON (B)(6) 2012, THE PATIENT UNDERWENT THEIR THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE UPPER RIGHT AND LEFT LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2012, FOLLOWING THE THIRD BRONCHIAL THERMOPLASTY TREATMENT, THE PATIENT EXPERIENCED SEVERE ASTHMA EXACERBATION AND WAS ADMITTED TO THE HOSPITAL AT 3:06 PM. THE PATIENT WAS TREATED MEDICALLY WITH NEBULIZED BRONCHODILATORS, SOLU-MEDROL AND A CONTINUATION OF HER USUAL TAKE-HOME MEDICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012 AT 9:53 AM, WITH INSTRUCTIONS TO TAKE AN ADDITIONAL 50 MG OF PREDNISONE FOR FIVE DAYS, RESUMING ALL OTHER HOME MEDICATIONS. NO EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON (B)(6) 2012, THE EVENT OF ASTHMA EXACERBATION WAS REPORTED AS RESOLVED. ADDITIONAL INFORMATION RECEIVED AS OF (B)(4) 2013. ACCORDING TO THE COMPLAINANT, THE EVENT OF EXACERBATED ASTHMA WAS CONSIDERED RESOLVED AS OF (B)(6) 2012.

    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), 2012 AS PART OF THE POST APPROVAL 2 (PAS2) CLINICAL STUDY. ON (B)(6), 2012, THE PATIENT UNDERWENT THEIR THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE UPPER RIGHT AND LEFT LOBES OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2012, FOLLOWING THE THIRD BRONCHIAL THERMOPLASTY TREATMENT, THE PATIENT EXPERIENCED SEVERE ASTHMA EXACERBATION AND WAS ADMITTED TO THE HOSPITAL AT 3:06 PM. THE PATIENT WAS TREATED MEDICALLY WITH NEBULIZED BRONCHODILATORS, SOLU-MEDROL AND A CONTINUATION OF HER USUAL TAKE-HOME MEDICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6), 2012 AT 9:53 AM, WITH INSTRUCTIONS TO TAKE AN ADDITIONAL 50 MG OF PREDNISONE FOR FIVE DAYS, RESUMING ALL OTHER HOME MEDICATIONS. NO EMERGENCY ROOM VISITS OCCURRED AS A RESULT OF THIS EVENT. ON JANUARY 18, 2012, THE EVENT OF ASTHMA EXACERBATION WAS REPORTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRONCHIAL THERMOPLASTY CATHETER BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 030110-161

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R