BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 7591032 · Received June 12, 2018

    Report

    Report Number
    1820334-2018-01678
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    February 8, 2018
    Report Date
    September 19, 2018
    Manufacturer
    COOK INC
    Product Code
    BWC
    PMA / PMN Number
    K013241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: A REVIEW OF DRAWINGS, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, TRENDS AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATION COULD BE PERFORMED. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. A COMPLAINT HISTORY SEARCH WAS ALSO UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. THE IFU HAS A WARNING THAT STATES: THE ENCLOSED BLOCKER BALLOON IS A HIGH-VOLUME, LOW-PRESSURE DESIGN. EXCESSIVE MANIPULATION OVER A PROLONGED PERIOD MAY CAUSE BALLOON RUPTURE OR DEFLATION. UNDER THE PRECAUTIONS THE IFU STATES: THIS PRODUCT IS INTENDED FOR USE BY CLINICIANS TRAINED AND EXPERIENCED IN THE USE OF BRONCHOSCOPES AND AIRWAYS ANATOMY. STANDARD TECHNIQUES FOR USE OF BRONCHOSCOPES AND ENDOBRONCHIAL BLOCKERS SHOULD BE EMPLOYED. CAUTION IS RECOMMENDED WHEN WORKING NEAR THE HILUM. THE BALLOON POSITION SHOULD BE VERIFIED TO PREVENT INADVERTENT BALLOON DAMAGE. CARE SHOULD BE TAKEN TO ENSURE THE BALLOON REMAINS FULLY INFLATED DURING LONGER PROCEDURES. DURING ONE-LUNG VENTILATION, THE PATIENT SHOULD BE PARALYZED TO HELP PREVENT DISLODGEMENT OF THE BALLOON. FOLLOWING INSERTION OF THE BLOCKER BALLOON THROUGH THE MULTIPORT ADAPTER, THE BALLOON SHOULD BE TEST INFLATED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT WAS ESCALATED, HOWEVER, DUE TO INSUFFICIENT INFORMATION REGARDING THE EVENT, DEVICE AND PATIENT, AND NO OBSERVED TREND, FURTHER ACTION WILL NOT BE TAKEN. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    CORRECTION: THERE ARE THREE DIFFERENT DATES REPORTED BY THE PHYSICIAN FOR THE THREE EVENTS. THEY ARE (B)(6) 2017, (B)(6) 2017, AND (B)(6) 2018. IT UNKNOWN WHICH EVENT DATE GOES WITH WHICH PATIENT. ADDITIONAL QUESTIONS HAVE BEEN TO CLARIFY THIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED ON 06/19/2018 PERTAINS TO ALL THREE REPORTS (MEDWATCH 1820334-2018-01676, MEDWATCH 1820334-2018-01678, MEDWATCH 1820334-2018-01677) AS THERE WAS NO INFORMATION PROVIDED TO DETERMINE WHICH PATIENT AND EVENT DATE THE INFORMATION PERTAINS TO. THERE WAS NO UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ONE PATIENT HAD A REPEATED BLOCKER PLACED, AND THE OTHER TWO PATIENTS HAD THE BLOCKERS PULLED OUT. THE PATIENTS HAD REPEATED BRONCHOSCOPIES. ONCE THE BLOCKER FAILED ON ONE PATIENT IT WAS REMOVED ALTOGETHER AND A NEW BLOCKER WAS PLACED AND ALSO FAILED. ON THE OTHER TWO PATIENTS THE BLOCKERS WERE REMOVED ALTOGETHER ONCE THEY FAILED. FURTHER QUESTIONS HAVE BEEN ASKED TO OBTAIN ADDITIONAL INFORMATION REGARDING EACH PATIENT, WHICH DATE OF EVENT IS FOR WHICH PATIENT AND FURTHER DETAILS OF BEFORE, DURING AND AFTER EACH EVENT. AT THIS TIME NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE EVENT.

    Additional Manufacturer Narrative · 1

    BASED ON DEVICE NAME PHYSICIAN REPORTED. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO A COOK REPRESENTATIVE DURING A CONFERENCE HE HAD RECEIVED A BATCH OF ARNDT ENDOBRONCHIAL BLOCKER BALLOONS THAT COLLAPSED AFTER LESS THAN 12 HOURS IN USE. AS REPORTED, THE DOCTOR STATED THIS DEFECT OCCURRED THREE TIMES. MEDWATCH 1820334-2018-01677 IS BEING REPORTED AS DEVICE MALFUNCTIONS WITH NO PATIENT HARM. MEDWATCH 1820334-2018-01676 IS REPORTING A PATIENT DEATH. TO DATE, ADDITIONAL INFORMATION IS UNABLE TO BE PROVIDED BY THE REPORTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432427 ARNDT ENDOBRONCHIAL BLOCKER SET BWC NEEDLE, EMERGENCY AIRWAY BWC COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1