BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 11474881 · Received March 12, 2021

    Report

    Report Number
    1820334-2021-00926
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    March 5, 2021
    Report Date
    February 18, 2022
    Manufacturer
    COOK INC
    Product Code
    CBI
    UDI-DI
    10827002441092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. DESCRIPTION OF EVENT: IT WAS REPORTED THAT THE BALLOON OF A ARNDT ENDOBRONCHIAL BLOCKER SET WAS LEAKING PRIOR TO PATIENT CONTACT. THE DEVICE WAS INTENDED TO BE USED FOR A FROZEN LUNG BIOPSY PROCEDURE. DURING A ROUTINE INSPECTION OF THE DEVICE PRIOR TO USE, THE USER INJECTED THE BALLOON WITH 2 ML OF AIR USING A SYRINGE. FOLLOWING, ONLY 1 ML OF AIR WAS ABLE TO BE EXTRACTED. REPEATED INSPECTION FOUND THAT THE EXTRACTED AIR WAS CONSISTENTLY LESS THAN THE INJECTED AIR. THE BALLOON WAS NOT USED AND WAS REPLACED BY A NEW DEVICE. INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES. COOK RECEIVED ONE OPENED DEVICE. THE BALLOON WAS INFLATED WITH AIR UNDER WATER AND AIR LEAKAGE WAS NOTED AT THE PROXIMAL END OF BALLOON. THERE WAS A SMALL PIN HOLE LOCATED ON THE PROXIMAL END OF THE BALLOON IN THE BONDING AREA CAUSING LEAKAGE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND ONE RELATED NONCONFORMANCE FOR ¿BALLOON LEAK.¿ THE NONCONFORMING DEVICES WERE SCRAPPED. THE NONCONFORMING DEVICES WERE SCRAPPED. THERE IS A 100% INSPECTION FOR THIS FAILURE. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. COOK CONCLUDED THAT NO NONCONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. 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 OR DEFLATION. HOW SUPPLIED: ¿-UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. COOK CONFIRMED A HOLE IN THE BALLOON TUBING. IT IS POSSIBLE THE DAMAGE OCCURRED DURING DEVICE HANDLING BEFORE THE PROCEDURE, HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF MANUFACTURING DEFICIENCY. THE CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    CUSTOMER (PERSON): STREET - (B)(6). 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 THAT THE BALLOON OF A ARNDT ENDOBRONCHIAL BLOCKER SET WAS LEAKING PRIOR TO PATIENT CONTACT. THE DEVICE WAS INTENDED TO BE USED FOR A FROZEN LUNG BIOPSY PROCEDURE. DURING A ROUTINE INSPECTION OF THE DEVICE PRIOR TO USE, THE USER INJECTED THE BALLOON WITH 2 ML OF AIR USING A SYRINGE. FOLLOWING, ONLY 1 ML OF AIR WAS ABLE TO BE EXTRACTED. REPEATED INSPECTION FOUND THAT THE EXTRACTED AIR WAS CONSISTENTLY LESS THAN THE INJECTED AIR. THE BALLOON WAS NOT USED AND WAS REPLACED BY A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367239 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC 10073310 10827002441092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown