BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 2462818 · Received February 21, 2012

    Report

    Report Number
    3005099803-2012-00607
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS 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) 2012. ON (B)(6) 2012, THE PATIENT SUCCESSFULLY COMPLETED THEIR FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2012, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND TREATMENT WITH IV STEROIDS AND BRONCHODILATORS IN A NEBULIZED FORM. THE EVENT RESOLVED APPROXIMATELY 4-5 DAYS LATER. WHILE HOSPITALIZED, THE PATIENT EXPERIENCED BRADYCARDIA (HEART RATE REPORTED AS BETWEEN 38 AND 60 BPM) AND HYPOTENSION. THE PATIENT'S HOSPITALIZATION WAS EXTENDED WHILE TESTS WERE PERFORMED TO DETERMINE THE ROOT CAUSE OF THESE EVENTS, AS WELL AS BEING EVALUATED FOR OTHER UNRELATED FINDINGS OF THYROID AND OVARIAN MASSES. THE ELECTROPHYSIOLOGY PHYSICIAN CONCLUDED THAT THE EVENTS OF BRADYCARDIA AND HYPOTENSION WERE DUE TO "MILD SINUS NODE DYSFUNCTION AND SOME THEOPHYLLINE EFFECT." ELECTROPHYSIOLOGICAL STUDIES WERE NEGATIVE FOR CARDIAC PATHOLOGY. IT WAS CONFIRMED BY THE PHYSICIAN THAT THESE EVENTS WERE NOT CAUSED BY THE BT PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. **UPDATE (B)(6) 2012** FOLLOW-UP VISIT ON (B)(6) 2012 REVEALED THAT THE PATIENT IS REPORTED AS "FEELING BETTER" AND HER LUNGS ARE CLEAR. IT WAS REPORTED THAT SHE WILL BE GOING FOR THYROID SURGERY FOR THE UNRELATED FINDING OF THYROID MASS THAT HAD BEEN DISCOVERED DURING HER HOSPITALIZATION.

    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) 2012. ON (B)(6) 2012, THE PATIENT SUCCESSFULLY COMPLETED THEIR FIRST BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2012, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND TREATMENT WITH IV STEROIDS AND BRONCHODILATORS IN A NEBULIZED FORM. THE EVENT RESOLVED APPROXIMATELY 4-5 DAYS LATER. WHILE HOSPITALIZED, THE PATIENT EXPERIENCED BRADYCARDIA (HEART RATE REPORTED AS BETWEEN 38 AND 60 BPM) AND HYPOTENSION. THE PATIENT'S HOSPITALIZATION WAS EXTENDED WHILE TESTS WERE PERFORMED TO DETERMINE THE ROOT CAUSE OF THESE EVENTS, AS WELL AS BEING EVALUATED FOR OTHER UNRELATED FINDINGS OF THYROID AND OVARIAN MASSES. THE ELECTROPHYSIOLOGY PHYSICIAN CONCLUDED THAT THE EVENTS OF BRADYCARDIA AND HYPOTENSION WERE DUE TO "MILD SINUS NODE DYSFUNCTION AND SOME THEOPHYLLINE EFFECT." ELECTROPHYSIOLOGICAL STUDIES WERE NEGATIVE FOR CARDIAC PATHOLOGY. IT WAS CONFIRMED BY THE PHYSICIAN THAT THESE EVENTS WERE NOT CAUSED BY THE BT PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALAIR BRONCHIAL THERMOPLASTY CATHETER ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES OOY BOSTON SCIENTIFIC - MARLBOROUGH M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization