BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 20674023 · Received November 13, 2024

    Report

    Report Number
    1820334-2024-01478
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    October 24, 2024
    Report Date
    April 24, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002480032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 - LEAD TECH. G4: PMA/510(K) # - K240589. H3: DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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

    SUMMARY OF EVENT: AS REPORTED, DURING AN ANGIOGRAM OF THE LOWER LEG, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET¿S WIRE "SHEARED OFF¿/SEPARATED UPON REMOVAL OF THE WIRE THROUGH THE ACCESS NEEDLE. ULTRASOUND-GUIDED ACCESS WAS REPORTEDLY OBTAINED IN THE LEFT POPLITEAL VEIN, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE, AND THE ANATOMY WAS REPORTEDLY CALCIFIED AND CHRONICALLY OCCLUDED. PER THE REPORTER THE SEPARATED TIP OF THE WIRE WAS LEFT IN THE ADVENTITIA OF THE POPLITEAL VEIN, AS IT WAS NOT EXPECTED TO CAUSE ADVERSE EFFECTS. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE WIRE WAS RETURNED WITHIN THE SHEATH, NOT THE NEEDLE. THE WIRE WAS UNRAVELED AND SEPARATED, AND THE SHEATH TIP WAS EXTREMELY DAMAGED/DISTORTED. 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 RETURNED WITHIN THE SHEATH. THE DISTAL PORTION OF THE MANDRIL PROTRUDED FROM THE DISTAL TIP, AND THE WIRE WAS ELONGATED AND UNRAVELED. THE TIP SOLDER WAS MISSING FROM THE END OF THE WIRE. THE SHEATH TIP WAS HEAVILY DAMAGED AND BENT APPROXIMATELY TWO CENTIMETERS FROM THE END. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND ONE RELEVANT NON-CONFORMANCE ON ONE DEVICE FROM A SUB-ASSEMBLY LOT; HOWEVER, THE AFFECTED PRODUCT WAS SCRAPPED. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES ¿DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE; BREAKAGE MAY RESULT.¿ 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. ALTHOUGH ONE RELEVANT NON-CONFORMANCE WAS NOTED ON A SUB-ASSEMBLY LOT, THE NON-CONFORMING PRODUCT WAS SCRAPPED, THERE ARE 100% INSPECTIONS IN PLACE TO CAPTURE THIS NON-CONFORMANCE, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT-RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. THEREFORE, IT WAS CONCLUDED THAT 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 UNINTENDED USER ERROR LIKELY CONTRIBUTED TO THIS EVENT. ALTHOUGH THE WIRE WAS RETURNED INSIDE THE SHEATH, THE USER REPORTED THAT THE WIRE WAS REMOVED THROUGH THE ACCESS NEEDLE. THE IFU STATES ¿DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE; BREAKAGE MAY RESULT.¿ IT IS ALSO POSSIBLE THAT THE PATIENT¿S CALCIFIED AND OCCLUDED ANATOMY CONTRIBUTED TO THE EVENT, AS RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE. 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 AN ANGIOGRAM OF THE LOWER LEG, A MICROPUNCTURE TRANSITION LESS STIFFENED CANNULA ACCESS SET¿S WIRE "SHEARED OFF¿/SEPARATED UPON REMOVAL OF THE WIRE THROUGH THE ACCESS NEEDLE. ULTRASOUND-GUIDED ACCESS WAS REPORTEDLY OBTAINED IN THE LEFT POPLITEAL VEIN, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. RESISTANCE WAS ENCOUNTERED UPON INSERTION OF THE DEVICE, AND THE ANATOMY WAS REPORTEDLY CALCIFIED AND CHRONICALLY OCCLUDED. PER THE REPORTER THE SEPARATED TIP OF THE WIRE WAS LEFT IN THE ADVENTITIA OF THE POPLITEAL VEIN, AS IT WAS NOT EXPECTED TO CAUSE ADVERSE EFFECTS. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE WIRE WAS RETURNED WITHIN THE SHEATH, NOT THE NEEDLE. THE WIRE WAS UNRAVELED AND SEPARATED, AND THE SHEATH TIP WAS EXTREMELY DAMAGED/DISTORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421351 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G48003 16057174 00827002480032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other