BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 5338472 · Received December 31, 2015

    Report

    Report Number
    3005099803-2015-03744
    Event Type
    Injury
    Date Received
    December 31, 2015
    Report Date
    December 5, 2015
    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 PATIENT'S AGE WAS NOT REPORTED, HOWEVER, IT WAS NOTED THAT THE PATIENT WAS (B)(6).. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION REQUIRING HOSPITALIZATION AND MEDICAL TREATMENT. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT ALL THREE BRONCHIAL THERMOPLASTY PROCEDURES. THE PROCEDURES OCCURRED LESS THAN A YEAR AGO. THE PATIENT WAS SUBSEQUENTLY FOLLOWED AT THE VA MEDICAL CENTER IN BALTIMORE AND ENDED UP HAVING "SEVERE OR RETURN OF ASTHMA FLARE UPS". THE PATIENT WAS ON A VENTILATOR TWICE SINCE RECEIVING BT AND WAS SEEN IN THE EMERGENCY ROOM A COUPLE OF TIMES. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE. THERE WAS NO INFORMATION PROVIDED INDICATING WHICH BT PROCEDURE THIS EVENT FOLLOWED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION REQUIRING HOSPITALIZATION AND MEDICAL TREATMENT. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT ALL THREE BRONCHIAL THERMOPLASTY PROCEDURES. THE PROCEDURES OCCURRED LESS THAN A YEAR AGO. THE PATIENT WAS SUBSEQUENTLY FOLLOWED AT THE (B)(6) MEDICAL CENTER IN (B)(6) AND ENDED UP HAVING "SEVERE OR RETURN OF ASTHMA FLARE UPS." THE PATIENT WAS ON A VENTILATOR TWICE SINCE RECEIVING BT AND WAS SEEN IN THE EMERGENCY ROOM A COUPLE OF TIMES. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE. THERE WAS NO INFORMATION PROVIDED INDICATING WHICH BT PROCEDURE THIS EVENT FOLLOWED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON JANUARY 5, 2016. THE PATIENT'S BT PROCEDURES WERE PERFORMED AT (B)(6) ON THE FOLLOWING DATES: PROCEDURE 1: (B)(6) 2013. PROCEDURE 2: (B)(6) 2013. PROCEDURE 3: (B)(6) 2014. THE PATIENT PRESENTED TO THE (B)(6) HOSPITAL EMERGENCY DEPARTMENT ON THE FOLLOWING DATES: (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015, (B)(6) 2015. THE PATIENT DID NOT PRESENT FOR CARE IN (B)(6) UNTIL 2015, THEREFORE, NO INFORMATION WAS REPORTED REGARDING POST PROCEDURE COMPLICATIONS. THE PATIENT WAS RECEIVING CARE IN (B)(6) BEFORE THAT, THROUGH THE (B)(6). THE PATIENT WAS ADMITTED EACH TIME PRESENTED AND WAS INTUBATED ON (B)(6) 2015 AND ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861449 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R