BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 21139414 · Received January 13, 2025

    Report

    Report Number
    1820334-2025-00048
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    January 2, 2025
    Report Date
    June 9, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002480087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE UNRAVELED DURING AN UNKNOWN PROCEDURE. ULTRASOUND-GUIDED ACCESS WAS OBTAINED, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. THE ACCESS SITE (GROIN) WAS NOT SCARRED OR CALCIFIED. THE WIRE REPORTEDLY BECAME STUCK IN THE ACCESS NEEDLE. THE USER THEN ATTEMPTED TO REMOVE THE WIRE BACKWARDS THROUGH THE NEEDLE; HOWEVER, THE WIRE COULD NOT BE REMOVED. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER, LOSING ACCESS. PER THE REPORTER, THE FLOPPY TIP OF THE WIRE WAS "STRETCHED OUT". THE PROCEDURE WAS COMPLETED AFTER OPENING ANOTHER KIT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 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 WIRE WAS UNRAVELED APPROXIMATELY 33-CENTIMETERS FROM THE PROXIMAL END. OFF-SET COILS WERE NOTED AT 42.4-CENTIMETERS. THE OUTER DIAMETER OF THE WIRE AND INNER DIAMETER OF THE NEEDLE WERE MEASURED AND WITHIN SPECIFICATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE FINAL, RAW MATERIAL, 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. WITHDRAWAL OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE MANDRIL WIRE GUIDE THROUGH A NEEDLE TIP MAY RESULT IN BREAKAGE.¿ THE IFU ALSO STATES ¿DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE; BREAKAGE MAY RESULT. IF THE WIRE GUIDE TIP MUST BE WITHDRAWN WHILE THE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT.¿ 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 FAILURE TO FOLLOW INSTRUCTIONS CONTRIBUTED TO THIS EVENT. THE USER REPORTEDLY ATTEMPTED TO REMOVE THE WIRE BACKWARDS THROUGH THE NEEDLE WHEN THE WIRE BECAME STUCK. THE IFU STATES ¿DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT. WITHDRAWAL OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE MANDRIL WIRE GUIDE THROUGH A NEEDLE TIP MAY RESULT IN BREAKAGE.¿ THE IFU ALSO STATES ¿DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE; BREAKAGE MAY RESULT. IF THE WIRE GUIDE TIP MUST BE WITHDRAWN WHILE THE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT.¿ 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, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE UNRAVELED DURING AN UNKNOWN PROCEDURE. ULTRASOUND-GUIDED ACCESS WAS OBTAINED, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. THE ACCESS SITE (GROIN) WAS NOT SCARRED OR CALCIFIED. THE WIRE REPORTEDLY BECAME STUCK IN THE ACCESS NEEDLE. THE USER THEN ATTEMPTED TO REMOVE THE WIRE BACKWARDS THROUGH THE NEEDLE; HOWEVER, THE WIRE COULD NOT BE REMOVED. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER, LOSING ACCESS. PER THE REPORTER, THE FLOPPY TIP OF THE WIRE WAS "STRETCHED OUT". THE PROCEDURE WAS COMPLETED AFTER OPENING ANOTHER KIT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517278 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G48008 16356033 00827002480087

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male