BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 8617112 · Received May 16, 2019

    Report

    Report Number
    1820334-2019-01231
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 5, 2019
    Report Date
    August 6, 2019
    Manufacturer
    COOK INC
    Product Code
    CBI
    UDI-DI
    00827002441200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND TRENDS, AS WELL AS A FUNCTIONAL TEST, VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A BALLOON CATHETER WAS RETURNED FOR EVALUATION. NO SURFACE DAMAGE WAS NOTED, AND RELEVANT MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATION. A LEAK TEST WAS PERFORMED, WITH THE BALLOON BEING SUBMERGED WHILE INFLATED. AIR BUBBLES WERE NOTED, AND SOME DEFLATION WAS VISIBLE OVER THE COURSE OF 30 SECONDS. THERE APPEARS TO BE A PINHOLE LEAK IN THE BALLOON NEAR OR ON THE BONDED AREA. DUE TO THIS PINHOLE, BALLOON MEASUREMENTS COULD NOT BE COMPLETED ACCURATELY. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT¿S DESIGN HISTORY FILE SHOWS EVIDENCE OF VERIFICATIONS IN PLACE TO MEET DESIGN REQUIREMENTS RELATED TO THIS FAILURE MODE. A REVIEW OF THE DEVICE HISTORY FILE FOUND NO NONCONFORMANCES IN LOT NS9181292 THAT COULD HAVE CONTRIBUTED TO THE FAILURE MODE. IT SHOULD BE NOTED THAT ONE OTHER COMPLAINT WAS REPORTED IN THIS LOT THAT CONCERNS A SEPARATE FAILURE MODE FOR A MISSING COMPONENT, AND THIS, IS UNRELATED TO THIS COMPLAINT. THERE IS NO EVIDENCE TO SUGGEST THAT NONCONFORMING PRODUCT 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: PRECAUTIONS: THIS PRODUCT IS INTENDED FOR USE BY CLINICIANS TRAINED AND EXPERIENCED IN THE USE OF BRONCHOSCOPES AND AIRWAY ANATOMY. STANDARD TECHNIQUES FOR USE OF BRONCHOSCOPES AND ENDOBRONCHIAL BLOCKERS SHOULD BE EMPLOYED. FOLLOWING INSERTION OF THE BLOCKER BALLOON THROUGH THE MULTIPORT ADAPTER, THE BALLOON SHOULD BE TEST INFLATED. HOW SUPPLIED: UPON REMOVAL FORM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD BE TRACED TO A COMPONENT FAILURE UNRELATED TO DESIGN OR MANUFACTURING ISSUES. THE PINHOLE LEAK WAS NOTED PRIOR TO PATIENT CONTACT, SO TORTUOUS PATIENT ANATOMY COULD NOT HAVE BEEN THE CAUSE. IT IS POSSIBLE THAT THE PINHOLE WAS CAUSED BY MANIPULATION DURING THE REPORTED INFLATION TESTING, BUT THIS CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. APPROPRIATE MEASURES HAVE BEEN TAKEN TO INVESTIGATE THIS 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. 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.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: TELEFLEX EZ BLOCKER. PHONE: (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 THE CATHETER FROM AN ARNDT ENDOBRONCHIAL BLOCKER SET LEAKED DURING AN INFLATION TEST PRIOR TO AN UNKNOWN PROCEDURE. TO COMPLETE THE PROCEDURE, THE OPERATOR PERFORMED ONE LUNG VENTILATION WITH ANOTHER ENDOBRONCHIAL BLOCKER FROM ANOTHER MANUFACTURER. THE PRODUCT DID NOT MAKE CONTACT WITH THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT DEMOGRAPHICS OR PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409938 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC N/A NS9181292 00827002441200

    Patients

    Seq Age Sex Outcome Treatment
    1