BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAIR BRONCHIAL THERMOPLASTY RF CONTROLLER

    MDR report key: 3033742 · Received April 3, 2013

    Report

    Report Number
    3005099803-2013-02334
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OOY
    PMA / PMN Number
    P080032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DEVICE PASSED ALL PERFORMANCE CRITERIA OF ITS FINAL TEST PROCEDURE. NO MALFUNCTION WAS REPORTED DURING ALL TESTS THAT COULD ACCOUNT FOR THE CUSTOMER'S REPORTED COMPLAINT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #'S 3005099803-2013-02332, 3005099803-2013-02333 AND 3005099803-2013-02334. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ALAIR BRONCHIAL THERMOPLASTY CATHETERS (MFR# 3005099803-2013-02332 AND MFR# 3005099803-2013-02333) AND A CONTROLLER (MFR# 3005099803-2013-02334) WERE USED DURING A BRONCHIAL THERMOPLASTY (BT) PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS FIRST BRONCHIAL THERMOPLASTY PROCEDURE TO THE RIGHT LOWER LOBE (RLL) OF THE LUNGS. NO VISIBLE ISSUES WERE NOTED WITH THE DEVICES. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, WITH OXYGEN USE REPORTED AS 100% TO 68% DURING THE PROCEDURE (DETAILS UNKNOWN). THE PHYSICIAN BEGAN TREATING THE PATIENT AND COMPLETED APPROXIMATELY 10-15 ACTIVATIONS WHEN A SPARK WITH SOME SMOKE WAS NOTED IN THE RLL. NO ERROR MESSAGES WERE OBSERVED ON THE CONTROLLER. THE CATHETER WAS REMOVED, AT WHICH TIME THE CATHETER HANDLE ICON WAS ILLUMINATED. IT WAS REPORTED THAT THE CATHETER ICON WENT ON PRIOR TO THE CATHETER BEING CLEANED. THE CATHETER WAS REPLACED AND THE PHYSICIAN CONTINUED THE PROCEDURE, COMPLETING APPROXIMATELY 40+ ACTIVATIONS. HOWEVER, WHILE TREATING THE RIGHT MAIN STEM BRONCHUS, SEVERE BLANCHING WAS NOTED AND CHARACTERIZED BY THE PHYSICIAN AS 'SECOND DEGREE BURNS.' AT THIS POINT, THE PHYSICIAN TERMINATED THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE ROOM WAS VERY COLD AND DRY DURING THE PROCEDURE. DURING ENERGY DELIVERY, THE PHYSICIAN STATED THAT ALL ELECTRODES WERE IN CONTACT WITH THE AIRWAY WALL; THE PATIENT WAS NOT MOVING OR COUGHING. IN ADDITION, THE CONTROLLER WAS PROPERLY GROUNDED AND NO MODIFICATIONS OR ADJUSTMENTS WERE MADE TO THE PATIENT RETURN ELECTRODE PADS. THE LOCATION IN THE AIRWAY WHERE THE EVENT OCCURRED HAD NOT BEEN PREVIOUSLY TREATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE. THE PATIENT WAS TREATED WITH HIS STANDARD ASTHMA MEDICATIONS AND SENT HOME. REPORTEDLY, THE PATIENT RECENTLY UNDERWENT HIS SECOND BT TREATMENT TO THE LEFT LOWER LOBE ON (B)(6) 2013 AND HAD NO COMPLICATIONS DUE TO THIS EVENT. THE PHYSICIAN STATED THAT WHEN HE LOOKED AT THE PREVIOUSLY AFFECTED AREAS, 'THERE WAS NOTHING THERE. EVERYTHING LOOKED FINE.' IMAGES TAKEN DURING THIS PROCEDURE OF THE PREVIOUSLY TREATED SITE WILL BE SENT TO BSC FOR REVIEW. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE SITE, INCLUDING ANESTHESIA RECORDS, AND ANY ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE DFU FOR THE CONTROLLER HAS THE FOLLOWING PRECAUTIONS: WHILE USING THIS DEVICE IN OXYGEN-ENRICHED ATMOSPHERES, NITROUS OXIDE (N2O) ATMOSPHERES, OR IN THE PRESENCE OF OTHER OXIDIZING AGENTS, FOLLOW APPROPRIATE GUIDELINES FOR REDUCING THE RISK OF SURGICAL FIRES. ENSURE THAT THE UNIT IS AT ROOM TEMPERATURE FOR ONE HOUR BEFORE USE IF UNIT HAS BEEN EXPOSED TO EXTREME TEMPERATURE CONDITIONS.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #'S 3005099803-2013-02332, 3005099803-2013-02333 AND 3005099803-2013-02334. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ALAIR BRONCHIAL THERMOPLASTY CATHETERS (MFR# 3005099803-2013-02332 AND MFR# 3005099803-2013-02333) AND A CONTROLLER (MFR# 3005099803-2013-02334) WERE USED DURING A BRONCHIAL THERMOPLASTY (BT) PROCEDURE ON (B)(6)2013. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HIS FIRST BRONCHIAL THERMOPLASTY PROCEDURE TO THE RIGHT LOWER LOBE (RLL) OF THE LUNGS. NO VISIBLE ISSUES WERE NOTED WITH THE DEVICES. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA, WITH OXYGEN USE REPORTED AS 100% TO 68% DURING THE PROCEDURE (DETAILS UNKNOWN). THE PHYSICIAN BEGAN TREATING THE PATIENT AND COMPLETED APPROXIMATELY 10-15 ACTIVATIONS WHEN A SPARK WITH SOME SMOKE WAS NOTED IN THE RLL. NO ERROR MESSAGES WERE OBSERVED ON THE CONTROLLER. THE CATHETER WAS REMOVED, AT WHICH TIME THE CATHETER HANDLE ICON WAS ILLUMINATED. IT WAS REPORTED THAT THE CATHETER ICON WENT ON PRIOR TO THE CATHETER BEING CLEANED. THE CATHETER WAS REPLACED AND THE PHYSICIAN CONTINUED THE PROCEDURE, COMPLETING APPROXIMATELY 40+ ACTIVATIONS. HOWEVER, WHILE TREATING THE RIGHT MAIN STEM BRONCHUS, SEVERE BLANCHING WAS NOTED AND CHARACTERIZED BY THE PHYSICIAN AS ¿SECOND DEGREE BURNS.¿ AT THIS POINT, THE PHYSICIAN TERMINATED THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE ROOM WAS VERY COLD AND DRY DURING THE PROCEDURE. DURING ENERGY DELIVERY, THE PHYSICIAN STATED THAT ALL ELECTRODES WERE IN CONTACT WITH THE AIRWAY WALL; THE PATIENT WAS NOT MOVING OR COUGHING. IN ADDITION, THE CONTROLLER WAS PROPERLY GROUNDED AND NO MODIFICATIONS OR ADJUSTMENTS WERE MADE TO THE PATIENT RETURN ELECTRODE PADS. THE LOCATION IN THE AIRWAY WHERE THE EVENT OCCURRED HAD NOT BEEN PREVIOUSLY TREATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE. THE PATIENT WAS TREATED WITH HIS STANDARD ASTHMA MEDICATIONS AND SENT HOME. REPORTEDLY, THE PATIENT RECENTLY UNDERWENT HIS SECOND BT TREATMENT TO THE LEFT LOWER LOBE ON (B)(6) 2013 AND HAD NO COMPLICATIONS DUE TO THIS EVENT. THE PHYSICIAN STATED THAT WHEN HE LOOKED AT THE PREVIOUSLY AFFECTED AREAS, ¿THERE WAS NOTHING THERE. EVERYTHING LOOKED FINE¿. IMAGES TAKEN DURING THIS PROCEDURE OF THE PREVIOUSLY TREATED SITE WILL BE SENT TO BSC FOR REVIEW. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE SITE, INCLUDING ANESTHESIA RECORDS, AND ANY ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE DFU FOR THE CONTROLLER HAS THE FOLLOWING PRECAUTIONS: - WHILE USING THIS DEVICE IN OXYGEN-ENRICHED ATMOSPHERES, NITROUS OXIDE (N2O) ATMOSPHERES, OR IN THE PRESENCE OF OTHER OXIDIZING AGENTS, FOLLOW APPROPRIATE GUIDELINES FOR REDUCING THE RISK OF SURGICAL FIRES. - ENSURE THAT THE UNIT IS AT ROOM TEMPERATURE FOR ONE HOUR BEFORE USE IF UNIT HAS BEEN EXPOSED TO EXTREME TEMPERATURE CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135769 ALAIR BRONCHIAL THERMOPLASTY RF CONTROLLER BRONCHIAL THERMOPLASTY SYSTEM OOY BOSTON SCIENTIFIC - MARLBOROUGH M005ATS20000 0062112052

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other