BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 10413929 · Received August 17, 2020

    Report

    Report Number
    1820334-2020-01503
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    May 7, 2020
    Report Date
    August 17, 2020
    Manufacturer
    COOK INC
    Product Code
    CBI
    UDI-DI
    10827002441207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER (PERSON): (B)(6). OCCUPATION: UNKNOWN. PMA/510(K) #: K160542. INVESTIGATION ¿ EVALUATION: (B)(6) HOSPITAL INFORMED COOK ON 03AUG2020 OF AN INCIDENT INVOLVING A ARNDT ENDOBRONCHIAL BLOCKER SET (RPN: C-AEBS-9.0-78-SPH-AS) FROM LOT # 9958606. THE BALLOON LEAKED WHILE INSERTING INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, WITH NO ADVERSE EFFECTS TO THE PATIENT NOTED. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATION COULD BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DESIGN HISTORY FILE (DHF) SHOWED THAT THE RISKS OF THIS DEVICE ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 9958606 FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿WARNINGS: THE ENCLOSED BLOCKER BALLOON IS A HIGH-VOLUME, LOW-PRESSURE DESIGN. EXCESSIVE MANIPULATION OVER A PROLONGED PERIOD MAY CAUSE BALLOON RUPTURE OF DEFLATION.¿ ¿PRECAUTIONS: CAUTION IS RECOMMENDED WHEN WORKING NEAR THE HILUM. THE BALLOON POSITION SHOULD BE VERIFIED TO PREVENT INADVERTENT BALLOON DAMAGE. INFLATE BALLOON INITIALLY UNDER DIRECT VISION TO ENSURE CORRECT POSITION AND PLACEMENT. FOLLOWING INSERTION OF THE BLOCKER BALLOON THROUGH THE MULTIPORT ADAPTER, THE BALLOON SHOULD BE TEST INFLATED.¿ FROM THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, DHF, AND IFU, COOK COULD NOT CONCLUDE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION, OR THAT THERE ARE NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE WITHOUT MANUFACTURING OR DESIGN DEFICIENCY CONTRIBUTED TO THE FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS FOUND TO LEAKING DURING A CAGG'S LEFT UPPER LOBECTOMY PROCEDURE. NO LEAK WAS OBSERVED PRIOR TO INSERTION. THE BALLOON LEAKED ONLY WHEN PRESSURE WAS APPLIED. ANOTHER ARNDT ENDOBRONCHIAL BLOCKER SET WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881178 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC N/A 9958606 10827002441207

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR