BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 3874428 · Received June 16, 2014

    Report

    Report Number
    3005099803-2014-02241
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    March 10, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT¿S EXACT AGE IS UNKNOWN, IT WAS REPORTED THE PATIENT WAS APPROXIMATELY (B)(6) YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, 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 PROCEDURE ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS THIRD BRONCHIAL THERMOPLASTY (BT) TREATMENT TO THE RIGHT AND LEFT UPPER LOBES OF THE LUNGS. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. NO ISSUES WERE NOTED TO THE DEVICE. THIS EVENT IS BEING REPORTED FOR THE EVENTS BEGINNING ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT WAS SEEN AT AN OUTPATIENT CLINIC WITH ONGOING SYMPTOMS OF SHORTNESS OF BREATH, A CHEST XRAY WAS PERFORMED AND WAS UNREMARKABLE. ON (B)(6) 2014, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND PRESENTED WITH SHORTNESS OF BREATH, COUGH, AND HEMOPTYSIS. THE PATIENT WAS OBSERVED FOR 24 HOURS IN HOSPITAL WITH NO EVIDENCE FOR ONGOING HEMOPTYSIS. A BRONCHOSCOPY WAS PERFORMED AND REVEALED A CLOT IN THE LEFT UPPER LOBE. THIS WAS REMOVED WITH SUCTION AND THERE WAS MINIMAL OOZING IN THE LEFT UPPER LOBE AND LINGUAL. THE PATIENT WAS SENT HOME WITH NO FURTHER HEMOPTYSIS. ON (B)(6) 2014, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND PRESENTED WITH BRIGHT RED BLOOD AND CLOTS FILLING A BASIN. THE PATIENT WAS ADMITTED TO THE MICU AND AN ANGIOEMOLIZATION WAS ATTEMPTED, HOWEVER, IT WAS UNSUCCESSFUL DUE TO TORTUOUS AND SMALL BRONCHIAL ARTERIES. THE PATIENT WAS SENT HOME ON (B)(6) 2014 WITH NO FURTHER BLEEDING. THE PATIENT RETURNED TO THE EMERGENCY ROOM ON (B)(6) 2014, WITH RECURRENT BLEEDING AND UNDERWENT BRONCHOSCOPY ¿ BLOOD IN THE LEFT UPPER LOBE AREA WAS ONCE AGAIN SEEN WITH THE ADULT SCOPE. THE PEDIATRIC SCOPE WAS THEN USED AND A SMALL POLYPOID LESION WAS SEEN IN THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE. THE POLYPOID LESION FELL OFF AND WAS SENT TO PATHOLOGY WHICH REPORTED SIMPLY BLOOD CLOTS AND BRONCHIAL WALL TISSUE WITH SOME EDEMA. THERE HAS BEEN NO FURTHER BLEEDING SINCE AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353336 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R