BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR¿

    MDR report key: 6600990 · Received May 31, 2017

    Report

    Report Number
    3005099803-2017-01696
    Event Type
    Injury
    Date Received
    May 31, 2017
    Report Date
    May 2, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE: EXACT AGE FOR THE SIX PATIENTS INVOLVED IN THIS STUDY WERE REPORTED A THE FOLLOWING (IN YEARS): (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. LITERATURE SOURCE - Z., QINGLING ET AL. "PRELIMINARY CLINICAL OBSERVATION OF BRONCHIAL THERMOPLASTY IN THE TREATMENT OF SEVERE BRONCHIAL ASTHMA." CHINESE JOURNAL OF TUBERCULOSIS AND RESPIRATORY DISEASES, 2016,39 (3): 183-188. DOI: 10.3760 / CMA.J.ISSN .1001-0939.2016.03.008. 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 THE BRONCHIAL THERMOPLASTY PROCEDURES REPORTED IN THE MEDICAL JOURNAL ARTICLE, ¿PRELIMINARY CLINICAL OBSERVATION OF BRONCHIAL THERMOPLASTY IN THE TREATMENT OF SEVERE BRONCHIAL ASTHMA¿, PUBLISHED IN THE CHINESE JOURNAL OF TUBERCULOSIS AND RESPIRATORY DISEASES. SIX PATIENTS WITH SEVERE ASTHMA WERE ENROLLED IN THE BT TREATMENTS FROM FEBRUARY TO JULY 2014. ALL PATIENTS UNDERWENT THE BT TREATMENTS IN THREE STAGES. EACH STAGE WAS AT LEAST THREE WEEKS APART; THE FIRST PROCEDURE WAS PERFORMED IN THE RIGHT LOWER LOBE OF THE BRONCHUS, THE SECOND PROCEDURE WAS PERFORMED IN THE LEFT LOWER LOBE, AND THE THIRD PROCEDURE WAS PERFORMED IN THE BILATERAL UPPER LOBE. THE EXACT PROCEDURE DATES WERE NOT REPORTED. NO DEVICE MALFUNCTIONS WERE REPORTED. ALL PATIENTS UNDERWENT LUNG FUNCTION TESTING, INCLUDING PULMONARY VENTILATION AND BRONCHODILATOR, AT 6 AND 12 MONTHS POSTOPERATIVELY. PATIENTS UNDERWENT CHEST IMAGING EXAMINATION ON DAY ONE, AND AGAIN 12 MONTHS POSTOPERATIVELY. THE FIRST AND SECOND BT TREATMENTS WERE SUCCESSFULLY COMPLETED WITH NO OBVIOUS COMPLICATIONS OF THE CASE. ACCORDING TO THE ARTICLE, SOME PATIENTS EXPERIENCED LOWER RESPIRATORY INFECTION FOLLOWING THE BT TREATMENT. ALL PATIENTS WERE GIVEN PROPHYLACTIC ANTIBIOTICS (MOXIFLOXACIN 400 MG, ONCE/DAY) ONE DAY BEFORE AND THREE DAYS AFTER THE BT PROCEDURE TO PREVENT INFECTION. THERE IS NO INFORMATION REGARDING ADDITIONAL TREATMENT NEEDED FOR THE RESPIRATORY INFECTION. ONE PATIENT EXPERIENCED ATELECTASIS, PNEUMOTHORAX, PNEUMOPERITONEUM, AND RESPIRATORY FAILURE TWELVE HOURS FOLLOWING THE THIRD BT TREATMENT. THIS PATIENT¿S RIGHT UPPER LOBE ALSO HAD STICKY SECRETIONS BLOCKING THE LUMEN. THE PHYSICIAN REPORTED THAT THIS PATIENT HAD A HISTORY OF TUBERCULOSIS (CT ALSO SUGGESTED THAT THE RIGHT UPPER LUNG TIP WITH OLD LESIONS), THE RIGHT UPPER LUNG PLEURA MAY HAVE ADHESIONS, AND RIGHT UPPER LUNG ATROPHY AFTER PULLING THE PLEURAL RUPTURE CAUSED BY PNEUMOTHORAX. THE PATIENT UNDERWENT TRACHEAL INTUBATION, DAILY BRONCHOSCOPY, CAVITY ASPIRATION AND NECROSIS (REMOVAL), PNEUMOTHORAX DRAINAGE, AND WAS PUT ON MECHANICAL VENTILATION FOR 4 DAYS. THE STUDY CONCLUDED THAT THESE EVENTS ARE ATTRIBUTED TO THE PATIENT¿S PRE-EXISTING CONDITION AND NOT DUE TO THE BRONCHIAL THERMOPLASTY PROCEDURE. ACCORDING TO THE ARTICLE, THE PATIENT¿S ¿BASIC LUNG FUNCTION IS POOR; THERE HAVE BEEN OLD TUBERCULOSIS, PLEURAL ADHESIONS AND OTHER FACTORS THAT MAY CAUSE POSTOPERATIVE ATELECTASIS, PNEUMOTHORAX, RESPIRATORY FAILURE.¿ ONE YEAR POSTOPERATIVE CHEST CT FOLLOW-UP WAS PERFORMED IN ALL PATIENTS INVOLVED IN THE STUDY, WHICH SHOWED NO BRONCHIAL STENOSIS OR EXPANSION OR OTHER STRUCTURAL CHANGES. PRE-BRONCHODILATOR (FOR ALL SIX PATIENTS): FEV1% OF ESTIMATED% (%): 92.6, 56.1, 66.5, 77.0, 52.2, 37.5. FVC% OF ESTIMATED VALUE% (%): 123.5, 84.7, 127.5, 102.1, 67.5, 63.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381713 ALAIR¿ BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - MARLBOROUGH M005ATS25010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other