BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRONCHIAL THERMOPLASTY CATHETER

    MDR report key: 3250084 · Received July 26, 2013

    Report

    Report Number
    3005099803-2013-07522
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). (B)(4). STUDY SOURCE: POST-FDA APPROVAL CLINICAL TRIAL EVALUATING BRONCHIAL THERMOPLASTY IN SEVERE PERSISTENT ASTHMA (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.

    Additional Manufacturer Narrative · 1

    A VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED DEVICE FOUND THAT ELECTRODES #2 AND #3 OF THE ARRAY WERE KINKED/BENT. VISUAL INSPECTIONS OF THE THERMOCOUPLE, SOLDER, SHAFT, AND HANDLE ALL VERIFIED NORMAL. THE REPORTED COMPLAINT OF INVERTED ARRAY WAS UNABLE TO BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT THE USER INTERPRETED THE ELECTRODE KINKS AS AN INVERTED ARRAY. THE KINKS LIKELY OCCURRED AS A RESULT OF ANATOMICAL/PROCEDURAL FACTORS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL SPECIFICATION REQUIREMENTS, ALLOWING THEM TO BE RELEASED FOR DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE DFU LIST BRONCHITIS AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THIS DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2013, AS PART OF THE POST APPROVAL 2 (B)(4) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ACUTE BRONCHITIS TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER SECOND BRONCHIAL THERMOPLASTY PROCEDURE TO THE LEFT LOWER LOBE ON (B)(6) 2013. DURING THE PROCEDURE, ONE ELECTRODE OF THE ELECTRODE ARRAY INVERTED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH ACUTE BRONCHITIS AND EXPERIENCED THE SYMPTOMS OF CHEST DISCOMFORT, COUGH, AND FEVER. THE PATIENT WAS TREATED WITH A Z-PAK AND PREDNISONE. THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(4) 2013. NO EMERGENCY ROOM VISITS OR HOSPITALIZATIONS OCCURRED AS A RESULT OF THIS EVENT. (B)(6) 2013. PRE-BRONCHODILATOR: FEV1: 3.03, FEV1 % PREDICTED: 94.10, FVC: 4.25, FVC % PREDICTED: 113.03, POST-BRONCHODILATOR: FEV1: 3.60, FEV1 % PREDICTED: 111.80, FVC: 4.50, FVC % PREDICTED: 119.68.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2013 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ACUTE BRONCHITIS TREATED WITH ANTIBIOTIC. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER SECOND BRONCHIAL THERMOPLASTY PROCEDURE TO THE LEFT LOWER LOBE ON (B)(6) 2013. DURING THE PROCEDURE, ONE ELECTRODE OF THE ELECTRODE ARRAY INVERTED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH ACUTE BRONCHITIS AND EXPERIENCED THE SYMPTOMS OF CHEST DISCOMFORT, COUGH, AND FEVER. THE PATIENT WAS TREATED WITH A Z-PAK AND PREDNISONE. THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. NO EMERGENCY ROOM VISITS OR HOSPITALIZATIONS OCCURRED AS A RESULT OF THIS EVENT. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2013. PRE-BRONCHODILATOR - FEV1: 3.03; FEV1 % PREDICTED: 94.10; FVC: 4.25; FVC % PREDICTED: 113.03. POST-BRONCHODILATOR - FEV1: 3.60; FEV1 % PREDICTED: 111.80; FVC: 4.50; FVC % PREDICTED: 119.68.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349939 BRONCHIAL THERMOPLASTY CATHETER BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - CORK M005ATS25010 CM-101712-016

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention