BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR?

    MDR report key: 4702211 · Received April 17, 2015

    Report

    Report Number
    3005099803-2015-00944
    Event Type
    Injury
    Date Received
    April 17, 2015
    Report Date
    March 20, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. (B)(4) - ATELECTASIS. (B)(4). 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 (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE IN THE LUNGS. ACCORDING TO THE LITERATURE, THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY TREATMENT ON SPONTANEOUS BREATHING IN DEEP SEDATION WITH REMIFENTANIL 0,10 MCG/KG/H AND PROPOFOL 8 MG/KG/H ADMINISTERED UNDER ANESTHESIOLOGY ASSISTANCE. COPIOUS MUCUS SECRETIONS AND HYPEREMIC BRONCHIAL MUCOSA WERE FOUND AT BRONCHOSCOPY EXAMINATION. FIFTY VALID ACTIVATIONS WERE ADMINISTERED IN THE BRONCHI OF THE RIGHT LOWER LOBE WITHOUT COMPLICATIONS. AFTER ONE HOUR, ACUTE RESPIRATORY FAILURE OCCURRED WITH PAO2/FIO2 < 300. ON PHYSICAL EXAMINATION, THERE WAS A REDUCTION OF BREATH SOUNDS IN THE RIGHT LOWER LOBE, SEVERE BRONCHOSPASM ELSEWHERE WITH TACHYPNEA. A CT SCAN SHOWED ATELECTASIS OF THE RIGHT LOWER AND MIDDLE LOBES. A NEW BRONCHOSCOPY WAS PERFORMED ON NON-INVASIVE VENTILATION WITH FACE MASK (ESPRIT VENTILATOR PHILIPS-RESPIRONICS INC. PVC/AC MODE; PERFORMAX FACE MASK PHILIPS-RESPIRONICS INC.) THROUGH RESPIRONICS SWIVEL CONNECTOR TO ENSURE ADEQUATE GAS EXCHANGE. RIGHT LOWER AND MIDDLE LOBE BRONCHI WERE ALMOST COMPLETELY OCCLUDED BY BRONCHUS-SHAPED PLUGS. THE REMOVAL OF THE PLUGS WAS VERY HARD DESPITE REPEATED WASHINGS WITH PHYSIOLOGICAL SALINE AND MECHANICAL FRAGMENTATION WITH FORCEPS. THE PATIENT HAD A RAPID RESOLUTION OF RESPIRATORY FAILURE WITH PROGRESSIVE IMPROVEMENT OF GAS EXCHANGE, AND WAS DISCHARGED AFTER TWELVE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256767 ALAIR? BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25020

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R