BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 21019627 · Received December 26, 2024

    Report

    Report Number
    1820334-2024-01687
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 12, 2024
    Report Date
    June 3, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002480087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION - "CCL." 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

    SUMMARY OF EVENT: AS REPORTED, DURING A PROCEDURE INVOLVING A RIGHT HEART CATHETERIZATION, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S INTRODUCER BROKE OFF IN THE PATIENT. RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE DEVICE INTO THE JUGULAR VEIN, AS THE ACCESS SITE HAD ¿A LOT¿ OF SCAR TISSUE FROM MULTIPLE PRIOR PROCEDURES. DURING INSERTION OF THE CANNULA, IT SEPARATED APPROXIMATELY ONE INCH BELOW THE HUB. THE HUB WAS REPORTEDLY INTACT. A SNARE WAS USED TO REMOVE THE SEPARATED FRAGMENT, AND ANOTHER MICROPUNCTURE SET WAS USED TO COMPLETE THE PROCEDURE. 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. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE OUTER CANNULA/CATHETER WAS SEPARATED AT 1.6-CENTIMETERS FROM THE HUB, AND THE DISTAL TIP WAS DAMAGED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE FINAL OR SUB-ASSEMBLY LOTS. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES ¿DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT.¿ 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 DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE CONTRIBUTED TO THE EVENT. 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 A RIGHT HEART CATHETERIZATION, A MICROPUNCTURE TRADITIONLESS STIFFENED CANNULA ACCESS SET¿S INTRODUCER BROKE OFF IN THE PATIENT. RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE DEVICE INTO THE JUGULAR VEIN, AS THE ACCESS SITE HAD ¿A LOT¿ OF SCAR TISSUE FROM MULTIPLE PRIOR PROCEDURES. DURING INSERTION OF THE CANNULA, IT SEPARATED APPROXIMATELY ONE INCH BELOW THE HUB. THE HUB WAS REPORTEDLY INTACT. A SNARE WAS USED TO REMOVE THE SEPARATED FRAGMENT, AND ANOTHER MICROPUNCTURE SET WAS USED TO COMPLETE THE PROCEDURE. 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
    2428702 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G48008 16320398 00827002480087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown