BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 8091133 · Received November 20, 2018

    Report

    Report Number
    1820334-2018-03263
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 24, 2018
    Report Date
    February 22, 2019
    Manufacturer
    COOK INC
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE EVALUATION: ONE USED, UNDAMAGED ENDOBRONCHIAL BLOCKER CATHETER WAS RETURNED FOR EVALUATION. THE PROXIMAL AND DISTAL BALLOON BOND DISTANCES BOTH MEASURED WITHIN SPECIFICATIONS. THE BALLOON WAS INFLATED WITH AIR AND SHOWED NO SIGNS OF DEFLATION OR LEAKAGE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. INVESTIGATION: A DOCUMENT-BASED INVESTIGATION REVIEWED THE FOLLOWING: COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL SPECIFICATIONS. THE DEVICE MASTER RECORD WAS REVIEWED, AND THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE IS MANUFACTURED TO SPECIFICATIONS. THE CUSTOMER COULD NOT PROVIDE THE LOT NUMBER OF THE COMPLAINT DEVICE, HOWEVER USING THE GLOBAL SALES WITH LOT NUMBERS REPORT, THE MANUFACTURER WAS ABLE TO DETERMINE THAT LOT OF THE COMPLAINT DEVICE IS LOT 9153635. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS ONE RELATED NONCONFORMING EVENT. THE NON CONFORMANCE WAS REPORTED FOR ONE DEVICE THAT WAS SCRAPPED BECAUSE THE BALLOON DID NOT STAY INFLATED DURING THE QC CHECK. AS THERE IS A 100% CHECK FOR THIS FAILURE MODE, THE DEVICE WAS SCRAPPED. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THERE IS NO EVIDENCE TO SUGGEST THERE ARE NON-CONFORMING PRODUCTS IN HOUSE OR IN FIELD. IFU STATES: INSTRUCTIONS FOR USE: ¿9. PLACE PATIENT IN FINAL POSITION. UNDER BRONCHOSCOPIC VISION, INFLATE THE BALLOON WITH AIR USING THE PILOT BALLOON ASSEMBLY. THE BALLOON SHOULD FILL THE ENTIRE ENDOBRONCHIAL LUMEN TO BE BLOCKED AND NOT HERNIATE INTO THE MAINSTREAM TRACHEA. DO NOT OVERINFLATE BALLOON.¿ FOR A FRENCH SIZE 9.0 CATHETER, THE RECOMMENDED AVERAGE INFLATION VOLUME IS 4.0 CC ¿ 8.0 CC. HOW SUPPLIED: ¿STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ CONCLUSION: BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, 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. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND NOTIFY APPROPRIATE PERSONNEL. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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 AN ARNDT ENDOBRONCHIAL BLOCKER SET DEFLATED WHILE BEING UTILIZED TO BLOCK A BLEED. APPROXIMATELY 36-HOURS AFTER IMPLANTATION, THE BALLOON DEFLATED FROM 8CC IN THE LEFT MAIN STEM. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY REVEALED THE DEVICE WAS ONLY INFLATED ONCE DURING IMPLANTATION AND WAS CHECKED TWICE DAILY. THE PHYSICIAN IS UNCERTAIN IF THE NURSING STAFF CHECKED/MANIPULATED THE DEVICE WHILE INFLATED BUT REPORTED THE PATIENT TO BE ASLEEP THE ENTIRE TIME. IT WAS ALSO PROVIDED THAT THE BALLOON DEVICE WAS NOT USED AS A TAMPONADE, BUT RATHER TO BLOCK THE BLEED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE AS THE BLEED WAS RESOLVED PRIOR TO DEFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930812 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC NA 9153635

    Patients

    Seq Age Sex Outcome Treatment
    1