BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 3140381 · Received May 31, 2013

    Report

    Report Number
    3005099803-2013-04417
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). PATIENT WEIGHT: (B)(6). (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 (BT) PROCEDURE ON (B)(6) 2013 AS PART OF THE (B)(4) STUDY. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER FIRST BT TREATMENT TO THE RIGHT LOWER LOBE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUES NOTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA AGGRAVATION. THE PATIENT DEVELOPED A WHEEZE POST BT TREATMENT AND WAS HOSPITALIZED. DURING HER HOSPITALIZATION, SHE WAS TREATED WITH INTRAVENOUS SOLU-MEDROL. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2013, THE EVENT OF ASTHMA AGGRAVATION WAS REPORTED TO BE RESOLVED. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(4) 2013. PRE-BRONCHODILATOR: FEV1: 2.22; FEV1 % PREDICTED: 90.24; FVC: 2.48; FVC % PREDICTED: 80.52. POST-BRONCHODILATOR: FEV1: 2.26; FEV1 % PREDICTED: 91.87; FVC: 2.54; FVC % PREDICTED: 82.47.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241562 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - SAN JOSE M005ATS25010 CM-061812-024

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization