BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 9557757 · Received January 7, 2020

    Report

    Report Number
    1820334-2020-00068
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 26, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002479449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF EVENT: AS REPORTED, DURING A CENTRAL VENOUS PORT PLACEMENT, THE WIRE GUIDE OF A COOK MICROPUNCTURE TRANSITIONLESS ACCESS SET UNRAVELED. THE WIRE GUIDE WAS INSERTED AFTER ACCESS WAS GAINED IN THE SUBCLAVIAN VEIN. UPON WITHDRAWAL OF THE WIRE, THE COIL OF THE WIRE GUIDE TIP UNRAVELED. THE WIRE WAS REPLACED WITH ANOTHER DEVICE 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 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, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THE RETURN OF ONE WIRE AND NEEDLE. THE COIL OF THE WIRE WAS ELONGATED THROUGH THE NEEDLE ENDING WITH THE DISTAL WELD BALL INTACT. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS ON THE PRODUCT LOT WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. A REVIEW OF THE SUBASSEMBLY LOT SHOWED THREE FAILURE-RELATED NONCONFORMANCES. ALL AFFECTED UNITS WERE SCRAPPED AND NOT REPLACED. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THE COMPLAINT DEVICE WAS THUS CONCLUDED TO HAVE BEEN MANUFACTURED TO SPECIFICATION. AN IFU IS PROVIDED WITH THIS DEVICE, WHICH NOTES "WHEN INSERTING, MANIPULATING OR WITHDRAWING A DEVICE THROUGH AN INTRODUCER, ALWAYS MAINTAIN INTRODUCER POSITION. DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT." THE IFU ALSO CAUTIONS, "DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE; BREAKAGE MAY RESULT." THE DEVICE IS PACKAGED WITH A DRAWING WARNING NOT TO PULL THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP. BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THE POTENTIAL CAUSE CAN BE TRACED TO UNINTENDED USER ERROR, AS THE WIRE WAS REMOVED THROUGH THE NEEDLE, WHICH IS SPECIFICALLY CAUTIONED AGAINST IN THE IFU AND DRAWING SUPPLIED WITH THE DEVICE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = K171275. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A CENTRAL VENOUS PORT PLACEMENT, THE WIRE GUIDE OF A COOK MICROPUNCTURE TRANSITIONLESS ACCESS SET UNRAVELED. THE WIRE GUIDE WAS INSERTED AFTER ACCESS WAS GAINED IN THE SUBCLAVIAN VEIN. UPON WITHDRAWAL OF THE WIRE, THE COIL OF THE WIRE GUIDE TIP UNRAVELED. THE WIRE WAS REPLACED WITH ANOTHER DEVICE 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 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
    24232 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G47944 9912597 00827002479449

    Patients

    Seq Age Sex Outcome Treatment
    1