BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 15491601 · Received September 27, 2022

    Report

    Report Number
    1820334-2022-01543
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    August 15, 2022
    Report Date
    February 16, 2023
    Manufacturer
    COOK INC
    Product Code
    CBI
    UDI-DI
    00827002441118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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. 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: (B)(6) HOSPITAL (JAPAN) INFORMED COOK THAT ON (B)(6) 2022 THE BALLOON IN AN ARNDT ENDOBRONCHIAL BLOCKER SET (RPN: C-AEBS-5.0-65-SPH-AS; LOT #: 14594765) INFLATED UNEVENLY. THE BALLOON WAS TEST INFLATED BEFORE USE. ANOTHER DEVICE WAS OPENED FROM THE SAME LOT AND WAS FOUND TO HAVE THE SAME PROBLEM. A THIRD DEVICE FROM ANOTHER LOT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. COOK RECEIVED TWO PRIOR TO USE AEBS DEVICES. THE INFLATION OF THE TWO DEVICE¿S BALLOONS FOUND THEY INFLATED UNEVENLY. THE BALLOONS INFLATION DIAMETER MEASURED WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK REVIEWED THE DEVICE HISTORY RECORD FOR LOT 14594765 AND RECORDS NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND ONE ADDITIONAL COMPLAINT REPORTED FROM THE SAME FACILITY AND WAS FOR THE SAME REPORTED FAILURE OF UNEVEN INFLATION. THE INVESTIGATION FOR THAT COMPLAINT CONCLUDED THAT THERE WAS NO PROBLEM DETECTED WITH THE DEVICE. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, C_T_AEBS_REV6 ¿ARNDT ENDOBRONCHIAL BLOCKER SET,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS ¿INFLATE BALLOON INITIALLY UNDER DIRECT VISION TO ENSURE CORRECT POSITION AND PLACEMENT.¿ INSTRUCTIONS FOR USE ¿1. FULLY DEFLATE THE BALLOON ON THE ENDOBRONCHIAL BLOCKER.¿ THE INFORMATION PROVIDED UPON REVIEW OF DMR, IFU, 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, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK DETERMINED THE ROOT CAUSE FOR THIS EVENT IS CUSTOMER DISSATISFACTION. THERE IS NO ISSUE WITH THE DEVICE AND THE PRODUCT MEETS MANUFACTURING SPECIFICATIONS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 A 4 YEAR OLD MALE PATIENT, WEIGHING 14 KGS, REQUIRED AN ARNDT ENDOBRONCHIAL BLOCKER SET. PRIOR TO PATIENT CONTACT, THE USER TESTED THE DEVICE FUNCTION AND FOUND THAT THE BALLOON INFLATED ONLY ON ONE SIDE. ANOTHER DEVICE, FROM THE SAME LOT, WAS ALSO TESTED AND RESULTED IN THE SAME ISSUE. THE BALLOON OF THE THIRD DEVICE, FROM A DIFFERENT UNKNOWN LOT, INFLATED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    2613605 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC N/A 14594765 00827002441118

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male