BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 20336545 · Received September 30, 2024

    Report

    Report Number
    1820334-2024-01287
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 11, 2024
    Report Date
    May 1, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002479425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3: OCCUPATION = RT G4: PMA/510(K) NUMBER = K240589. 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 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING A PROCEDURE INVOLVING Y-90 TREATMENT, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S WIRE UNRAVELED UPON REMOVAL OF THE DEVICE. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCING THE WIRE GUIDE. THE ACCESS SITE WAS NOT SCARRED OR CALCIFIED, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE DEVICE. THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED, AS WELL AS A SUPPLIER INVESTIGATION. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE WIRE WAS UNRAVELED NEAR THE DISTAL SOLDER, AND THE MANDRIL WAS BROKEN. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. THE RAW MATERIAL LOT PASSED INCOMING QUALITY CONTROL INSPECTIONS. A SEARCH OF ALL FINAL LOTS USING THE SAME RAW MATERIAL LOT AS THE COMPLAINT DEVICE FOUND NO RELEVANT NON-CONFORMANCES. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. A SEARCH OF ALL FINAL LOTS USING THE SAME RAW MATERIAL LOT AS THE COMPLAINT DEVICE FOUND NO ADDITIONAL COMPLAINTS. A SUPPLIER INVESTIGATION WAS CONDUCTED. THE SUPPLIER CONCLUDED THAT INADEQUATE/POOR SOLDERING TECHNIQUE LIKELY CAUSED THE WIRE TO UNRAVEL. THE SUPPLIER ISSUED TRAINING, AND INSTRUCTIONS WERE UPDATED TO PREVENT THIS TYPE OF FAILURE IN THE FUTURE. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE SUPPLIER INVESTIGATION AND EVALUATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION; HOWEVER, COOK HAS CONCLUDED THIS TO BE AN ISOLATED EVENT. THERE IS NO EVIDENCE THAT ADDITIONAL NON-CONFORMING PRODUCT EXISTS IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A SUPPLIER MANUFACTURING DEFICIENCY CONTRIBUTED TO THIS EVENT. THE SUPPLIER HAS IMPLEMENTED CORRECTIONS TO PREVENT THIS FAILURE MODE FROM OCCURRING IN THE FUTURE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    AS REPORTED, DURING A PROCEDURE INVOLVING Y-90 TREATMENT, A MICROPUNCTURE TRADITIONLESS ACCESS SET'S WIRE UNRAVELED UPON REMOVAL OF THE DEVICE. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCING THE WIRE GUIDE. THE ACCESS SITE WAS NOT SCARRED OR CALCIFIED, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE DEVICE. THE WIRE WAS NOT PULLED OR MANIPULATED BACKWARDS THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041415 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G47942 16153602 00827002479425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown