BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 5432218 · Received February 11, 2016

    Report

    Report Number
    3005099803-2016-00204
    Event Type
    Injury
    Date Received
    February 11, 2016
    Report Date
    January 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. 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 BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2015. ACCORDING TO THE PATIENT, WITHIN A FEW WEEKS OF THE BT PROCEDURE, THE PATIENT DEVELOPED A CHEST INFECTION ALONG WITH SEVERAL BREATHING PROBLEMS. REPORTEDLY, SHE STARTED FEELING A TIGHT BAND AROUND HER CHEST, ESPECIALLY IN COLD AIR. SHE STATED THAT SHE COULD NOT TAKE A FULL BREATH WITHOUT DISCOMFORT AND PAIN. IN ADDITION TO THE CHEST TIGHTNESS, SHE REPORTED GETTING BREATHLESS WHEN CLIMBING STAIRS OR WALKING UPHILL. SHE ALSO REPORTED THAT SHE IS MORE SENSITIVE TO STIMULANTS SUCH A MOLD. THE PATIENT STATES THAT PRIOR HER BT TREATMENT, SHE HAD BETTER ASTHMA CONTROL AND WAS TAKING LESS MEDICATION . THE PATIENT IS CURRENTLY ON THE FOLLOWING MEDICATIONS: ADVAIR HFA 230/21 2 PUFFS 2 TIMES DAILY, XOPENEX HFA 45 MCG 1 PUFF 4X (I USED TO TAKE IT 2-3 TMES, ZYRTEC, SINGULAIR 10 MG 1 TIME, FLUTICASONE NASAL SPRAY 16 GM 2 SPRAYS DAILY, SODIUM CHLORIDE 3% IN NEBULIZER SOLUTION 15 ML, 1/2 VIAL DAILY, PREDNISONE 40MG, ALSO, SPIRIVA RESPIMAT 2.5, 2 PUFFS DAILY HAS BEEN ADDED SINCE THE BT PROCEDURE.

    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 ON (B)(6) 2015. ACCORDING TO THE PATIENT, WITHIN A FEW WEEKS OF THE BT PROCEDURE, THE PATIENT DEVELOPED A CHEST INFECTION ALONG WITH SEVERAL BREATHING PROBLEMS. REPORTEDLY, SHE STARTED FEELING A TIGHT BAND AROUND HER CHEST, ESPECIALLY IN COLD AIR. SHE STATED THAT SHE COULD NOT TAKE A FULL BREATH WITHOUT DISCOMFORT AND PAIN. IN ADDITION TO THE CHEST TIGHTNESS, SHE REPORTED GETTING BREATHLESS WHEN CLIMBING STAIRS OR WALKING UPHILL. SHE ALSO REPORTED THAT SHE IS MORE SENSITIVE TO STIMULANTS SUCH A MOLD. THE PATIENT STATES THAT PRIOR HER BT TREATMENT, SHE HAD BETTER ASTHMA CONTROL AND WAS TAKING LESS MEDICATION . THE PATIENTS IS CURRENTLY ON THE FOLLOWING MEDICATIONS: ADVAIR HFA 230/21 2 PUFFS 2 TIMES DAILY, XOPENEX HFA 45 MCG 1 PUFF 4X (I USED TO TAKE IT 2-3 TIMES, ZYRTEC, SINGULAIR 10 MG 1 TIME, FLUTICASONE NASAL SPRAY 16 GM 2 SPRAYS DAILY, SODIUM CHLORIDE 3% IN NEBULIZER SOLUTION 15 ML, 1/2 VIAL DAILY, PREDNISONE 40MG, ALSO, SPIRIVA RESPIMAT 2.5, 2 PUFFS DAILY HAS BEEN ADDED SINCE THE BT PROCEDURE. CORRECTION: ACCORDING TO THE PATIENT, WITHIN A FEW WEEKS OF THE THIRD BT PROCEDURE, THE PATIENT DEVELOPED A CHEST INFECTION ALONG WITH SEVERAL BREATHING PROBLEMS. ADDITIONAL INFORMATION RECEIVED ON 15MAR2016. ON (B)(6) 2015, THE PATIENT UNDERWENT THE THIRD BT TREATMENT PERFORMED BY DR. (B)(6). THERE WAS NO MALFUNCTION WITH THE DEVICE. THE PATIENT WAS THEN FOLLOWED BY PULMONOLOGIST DR. (B)(6). ACCORDING TO DR. (B)(6), THE PATIENT'S ASTHMA SYMPTOMS IMPROVED SLIGHTLY POST BT TREATMENTS, HOWEVER, THE PATIENT HAS FLARE UPS EVERY FEW MONTHS. DR. (B)(6) DOES NOT BELIEVE THAT HER CURRENT SYMPTOMS ARE RELATED TO THE BT PROCEDURE. THE EXACT DATES OF THE FLARE UPS ARE UNKNOWN AS THIS PATIENT IS SEEN BY OTHER PHYSICIANS, PULMONOLOGISTS AND ALLERGISTS IN THE AREA. ADDITIONALLY, HE HAS NO INFORMATION REGARDING THE INFECTIONS SHE EXPERIENCED, AND NO KNOWLEDGE OF X-RAYS OR CT SCANS PERFORMED SINCE HER LAST BT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87275 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention