BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 20695276 · Received November 15, 2024

    Report

    Report Number
    1820334-2024-01493
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    November 7, 2024
    Report Date
    June 6, 2025
    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

    G4 - 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. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. COOK WAS INFORMED ON 07NOV2024 THAT THE BALLOON IN A C-AEBS-5.0-50-SPH-AS (ARNDT ENDOBRONCHIAL BLOCKER SET) WOULDN¿T INFLATE. THE BALLOON WAS INFLATED WITH 2-10 CC OF AIR WITH THE SYRINGE INCLUDED IN THE SET. IT WAS FOUND THE BALLOON WOULD NOT INFLATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS HAVE BEEN REPORTED. REVIEWS OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL PROCEDURES, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE COMPLETED DURING THE INVESTIGATION. ONE PRIOR TO USE DEVICE WAS RETURNED FOR EVALUATION. A FUNCTIONAL TEST CONFIRMED THAT THE DEVICE WOULD NOT HOLD AIR. A PINHOLE LEAK WAS IDENTIFIED ON THE BALLOON. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND ONE RELEVANT NONCONFORMANCE IN A SUBASSEMBLY LOT, IN WHICH 100% INSPECTIONS TOOK PLACE TO IDENTIFY THE FAILURE BEFORE SHIPPING AND THE DEVICE WAS SCRAPPED. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK WAS ABLE TO REVIEW PRODUCT LABELING. THE CURRENT PRODUCT IFU, [C_T_AEBS_REV6] ¿ARNDT ENDOBRONCHIAL BLOCKER SET,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS ¿FOLLOWING INSERTION OF THE BLOCKER BALLOON THROUGH THE MULTIPORT ADAPTER, THE BALLOON SHOULD BE TEST INFLATED.¿ INSTRUCTIONS FOR USE: ¿AVERAGE INFLATION VOLUMES. FRENCH SIZE- 5.0. BALLOON- PEDIATRIC SPHERICAL. INFLATION VOLUME- .5CC- 2.0CC¿. HOW SUPPLIED: ¿-UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ EVIDENCE PROVIDED UPON REVIEW OF DMR, IFU, DHR, AND THE DEVICE FAILURE ANALYSIS DOES NOT INDICATE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE EVENT. THE CUSTOMER STATED THAT THE BALLOON WAS TEST INFLATED WITH 2-10CC OF AIR. IT IS POSSIBLE THAT BALLOON WAS OVER-INFLATED DURING TESTING, CAUSING THE PINHOLE TO FORM. HOWEVER, THIS POSSIBILITY CANNOT BE DEFINITIVELY CONFIRMED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK 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

    IT WAS REPORTED THAT THE BALLOON INCLUDED IN ARNDT ENDOBRONCHIAL BLOCKER SET FAILED TO INFLATE DURING A ONE LUNG VENTILATION PROCEDURE FOR A PATIENT OF UNKNOWN AGE AND GENDER. PRIOR TO THE PROCEDURE, THE DEVICE OPERATORS PERFORMED A PRE-BALLOONING TEST USING THE SYRINGE INCLUDED IN THE SET TO INFLATE THE BALLOON WITH A VOLUME OF 2-10CC AND FOUND THAT THE BALLOON DID NOT INFLATE. ANOTHER LIKE DEVICE USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306723 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC G44109 NS14961837 10827002441092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown