BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 7659179 · Received July 3, 2018

    Report

    Report Number
    1820334-2018-01893
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 6, 2018
    Report Date
    August 8, 2018
    Manufacturer
    COOK INC
    Product Code
    CBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, OR UNAVAILABLE. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018 REPORTING THAT THE BALLOON WAS IN PLACE FOR APPROXIMATELY 15-30MINUTES. THE DEVICE WAS MONITORED WITH A PEDIATRIC FIBER OPTIC SCOPE AS WELL AS LISTENING FOR BREATH SOUNDS WHEN CLAMPED. THEY EXPERIENCED SLIGHT DIFFICULTY PLACING THE BRONCHIAL BLOCKER BUT NO EXCESSIVE FORCE WAS USED TO PLACE THE DEVICE. THE PATIENT WENT TO REHAB FOLLOWING DISCHARGE FROM THE HOSPITAL AND IS DOING FINE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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

    ADDITIONAL INFORMATION: B5: THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON 18SEP2018: UNDER FIBER OPTIC VISUALIZATION, THE BALLOON WAS INFLATED TO A SUFFICIENT AMOUNT THAT OCCLUDED THE BRONCHUS AND DID NOT HERNIATE. THE DEVICE WAS LUBRICATED PRIOR TO PLACEMENT. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE REPORTED DEVICE WAS NOT RETURNED TO COOK INC. FOR EVALUATION, HOWEVER, PHOTOGRAPHS OF THE DEVICE WERE SENT IN VIA EMAIL. THE PHOTOGRAPHS SHOWED THE BALLOON TO BE SEPARATED FROM THE CATHETER AND LODGED IN THE PATIENT¿S RIGHT MAIN STEM BRONCHUS. THE DISTAL END OF THE BALLOON APPEARED INVERTED, SUGGESTING THE BALLOON SEPARATED DURING A WITHDRAWING MOTION. 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 STATES TO DEFLATE THE BALLOON BEFORE ATTEMPTING TO REMOVE THE ENDOBRONCHIAL BLOCKER. IF IT IS NOT DEFLATED, IT MAY BECOME LODGED DURING WITHDRAWAL LIKE IN THIS COMPLAINT. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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 · 1

    (B)(4). PMA/510(K) #: K160542. 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

    IT WAS REPORTED A PATIENT INVOLVED IN A MOTORCYCLE ACCIDENT ON (B)(6) 2018 REQUIRED CHEST TUBE PLACEMENT DUE TO LEFT HEMOTHORAX/PNEUMOTHORAX. THE PATIENT RETURNED TO THE HOSPITAL AFTER BEING DISCHARGED AND WAS FOUND TO HAVE RESIDUAL HEMOTHORAX THAT TURNED INTO AN EMPYEMA. A LEFT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WAS PERFORMED TO CLEAR THE EMPYEMA. ON (B)(6) 2018 AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS USED FOR LUNG ISOLATION INSTEAD OF A DOUBLE LUMEN TUBE DUE TO PRIOR TRACHEOSTOMY. AFTER PLACEMENT OF THE DEVICE AND CONFIRMATION WITH A FIBEROPTIC SCOPE, THE PATIENT LOST END TIDAL CO2. THE PATIENT WAS UNABLE TO BE VENTILATED AND RECEIVED CPR. THE DEVICE WAS DEFLATED USING A 12CC SYRINGE AND REMOVED, HOWEVER, THE BALLOON DISLODGED IN THE PATIENT'S RIGHT MAIN STEM BRONCHUS. AS REPORTED, THE BALLOON WAS REMOVED EASILY. TO DATE, THE PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502019 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention