BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 5766023 · Received July 1, 2016

    Report

    Report Number
    3005099803-2016-01873
    Event Type
    Injury
    Date Received
    July 1, 2016
    Report Date
    June 8, 2016
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4). 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 (BT) CATHETER WAS USED DURING A BT PROCEDURE (EXACT DATE NOT REPORTED). THE PATIENT UNDERWENT THE SECOND BT TREATMENT SUCCESSFULLY WITH NO REPORTED ISSUES TO THE DEVICE. FOLLOWING THE BT PROCEDURE, WHILE VISITING AN ALLERGIST FOR HIS ALLERGIC RHINITIS, THE PATIENT REPORTED THAT HE HAD EXPERIENCED 'COMPLICATIONS' WHILE UNDERGOING THE SECOND BT PROCEDURE. THE PATIENT WAS INTUBATED AS PART OF THE BT PROCEDURE, HOWEVER THEY HAD TROUBLE WEANING HIM OFF THE VENTILATOR, SO THE PATIENT REMAINED ON THE VENTILATOR FOR A FEW EXTRA DAYS. THE PATIENT REMAINED IN THE HOSPITAL FOR THREE DAYS. THE ALLERGIST INDICATED THAT SHE DID NOT KNOW WHAT THE "COMPLICATIONS" WERE NOR DID SHE KNOW WHETHER THE INABILITY TO EXTUBATE THE PATIENT WAS DUE TO THE BT PROCEDURE, THE PATIENT'S SEVERE PULMONARY ISSUES, HIS CONGESTIVE HEART FAILURE (CHF), OR SOMETHING ELSE. THE ALLERGIST REPORTED THAT DURING AN OFFICE VISIT, THE PATIENT'S ASTHMA WAS STABILIZED AND MEDICATION WAS NOT REQUIRED TO KEEP THE ASTHMA UNDER CONTROL. ADDITIONALLY, THE PATIENT DID NOT EXPERIENCE ANY ACUTE FLARE UPS DURING HIS VISIT. ATTEMPTS TO OBTAIN ADDITIONAL DETAILS REGARDING THE 'COMPLICATIONS' HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420624 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization