BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 21219433 · Received January 23, 2025

    Report

    Report Number
    1820334-2025-00100
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    January 10, 2025
    Report Date
    June 16, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002438705
    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. 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 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 AN OPEN-HEART PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE UNRAVELED. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE FEMORAL ARTERY USING THE 21-GAUGE NEEDLE INCLUDED IN THE SET, AND BLOOD RETURN WAS NOTED. THE ACCESS SITE WAS CALCIFIED. UPON ADVANCEMENT OF THE WIRE INTO THE NEEDLE, THE WIRE BECAME STUCK WITHIN THE NEEDLE. THE PHYSICIAN ASSISTANT ATTEMPTED TO PULL THE WIRE BACKWARDS THROUGH THE NEEDLE; HOWEVER, IT COULD NOT BE REMOVED. THE USER THEN REMOVED THE WIRE AND NEEDLE TOGETHER, NOTING THAT THE WIRE HAD UNRAVELED ¿DISTAL¿ TO THE NEEDLE. SECONDARY ACCESS WAS OBTAINED, AND 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), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED AS WELL. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE WIRE GUIDE HAD BEGUN TO UNRAVEL AT THE SOLDERED JOINT AND WAS INSIDE OF THE NEEDLE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT OR SUBASSEMBLY LOTS. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELEVANT COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT¿S INSTRUCTIONS FOR USE (IFU) 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 A FAILURE TO FOLLOW INSTRUCTIONS HAS CONTRIBUTED TO THE FAILURE IN THIS INCIDENT. THE IFU WARNS, ¿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.¿ HOWEVER, THE USER ATTEMPTED TO PULL THE WIRE BACKWARDS THROUGH THE NEEDLE. 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 OPEN-HEART PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE UNRAVELED. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE FEMORAL ARTERY USING THE 21-GAUGE NEEDLE INCLUDED IN THE SET, AND BLOOD RETURN WAS NOTED. THE ACCESS SITE WAS CALCIFIED. UPON ADVANCEMENT OF THE WIRE INTO THE NEEDLE, THE WIRE BECAME STUCK WITHIN THE NEEDLE. THE PHYSICIAN ASSISTANT ATTEMPTED TO PULL THE WIRE BACKWARDS THROUGH THE NEEDLE; HOWEVER, IT COULD NOT BE REMOVED. THE USER THEN REMOVED THE WIRE AND NEEDLE TOGETHER, NOTING THAT THE WIRE HAD UNRAVELED ¿DISTAL¿ TO THE NEEDLE. SECONDARY ACCESS WAS OBTAINED, AND 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
    922373 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G43870 16186710 00827002438705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown