BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 21223840 · Received January 23, 2025

    Report

    Report Number
    1820334-2025-00106
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    December 10, 2024
    Report Date
    August 12, 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. CORRECTION: H6 - ANNEX A. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE BALLOON OF AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS FOUND TO BE DAMAGED PRIOR TO USE AND WAS REPLACED WITH ANOTHER ONE TO COMPLETE THE PROCEDURE. THE USER REPORTED USING 1ML OF AIR TO INFLATE THE BALLOON AND OBSERVED NO DIFFICULTY INFLATING IT. THE DEVICE WAS RETURNED TO COOK. DURING PRELIMINARY DEVICE FAILURE ANALYSIS, THE BALLOON WAS NOTED TO BE TORN NEAR THE BASE AND WOULD NOT INFLATE DUE TO THIS TEAR, THUS PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL PROCEDURES, MANUFACTURING INSTRUCTIONS AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. COOK RECEIVED ONE AEB CATHETER FROM THE CUSTOMER. VISUAL INSPECTION OF THE DEVICE CONFIRMED THE BALLOON WAS TORN NEAR THE BONDING SITE. 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) FOR THE DEVICE FOUND RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THERE ARE 100% INSPECTIONS IN PLACE TO IDENTIFY THIS FAILURE PRIOR TO SHIPPING AND ALL NON-CONFORMING MATERIAL WAS SCRAPPED. IT SHOULD BE NOTED THAT THERE WAS ONE OTHER COMPLAINT ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER FOR AN UNRELATED FAILURE. COOK ALSO REVIEWED 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 GATHERED UPON REVIEW OF DMR, PRODUCT LABELING, DHR, AND 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 DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. IT IS POSSIBLE THAT THE DEVICE WAS OVER INFLATED, HOWEVER THE CUSTOMER STATED THAT ONLY 1CC OF AIR WAS USED. 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 OF AN ARNDT ENDOBRONCHIAL BLOCKER SET WAS FOUND TO BE DAMAGED PRIOR TO USE AND WAS REPLACED WITH ANOTHER ONE TO COMPLETE THE PROCEDURE. THE USER REPORTED USING 1ML OF AIR TO INFLATE THE BALLOON AND OBSERVED NO DIFFICULTY INFLATING IT. THE DEVICE WAS RETURNED TO COOK. DURING PRELIMINARY DEVICE FAILURE ANALYSIS, THE BALLOON WAS NOTED TO BE TORN NEAR THE BASE AND WOULD NOT INFLATE DUE TO THIS TEAR, THUS PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723049 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC G44109 15913697 10827002441092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown