BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 7384725 · Received March 30, 2018

    Report

    Report Number
    1820334-2018-00722
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    March 7, 2018
    Report Date
    June 5, 2018
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002355514
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, QUALITY CONTROL, SPECIFICATIONS, INSTRUCTIONS FOR USE (IFU), AND MANUFACTURING INSTRUCTIONS AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE STIFFENING CANNULA WAS SEPARATED FROM THE INNER DILATOR. THE DILATOR PLASTIC PORTION CONNECTED TO THE HUB WAS 12CM IN LENGTH, WITH A 30 DEGREE BEND AT A DISTANCE OF 2CM FROM THE HUB OF THE DEVICE. THE STIFFENING CANNULA WAS 12.5 CM IN LENGTH, AND HAD A 12 DEGREE BEND THAT BEGAN 7CM FROM THE PROXIMAL END. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THE LOT WAS RELEASED MEETING ALL FINISHED GOODS RELEASE CRITERIA. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PMA/510(K) NUMBER = K133114. DEVICE EVALUATION BEGUN, BUT IS NOT YET COMPLETE. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BEGUN, BUT IS NOT YET COMPLETE. IT WAS REPORTED THAT WHILE ACCESSING THE PATIENT'S ARTERY FOR A LOWER EXTREMITY ANGIOGRAM, ONCE THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET NEEDLE WAS INSIDE OF THE ARTERY, THE SET WIRE GUIDE WAS INSERTED. AS THE WIRE GUIDE WAS BEING MANIPULATED, THE TIP BROKE OFF INSIDE OF THE PATIENT'S ANATOMY. THE STIFFENED CANNULA INTRODUCER THAT GOES OVER THE WIRE GUIDE WAS INSERTED AND THE PHYSICIAN MADE A SKIN KNICK TO ADVANCE. DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE INTRODUCER AND IT BENT A FEW TIMES, BUT THE PHYSICIAN WAS ABLE TO ADVANCE IT. UPON REMOVAL OF THE INTRODUCER, HOWEVER, METAL STIFFENING CANNULA WITHIN THE EXTERNAL TUBING COMPONENT OF THE DEVICE REMAINED INSIDE THE PATIENT ON THE NEEDLE TRACK. THE CANNULA WAS THEN ABLE TO BE GRABBED AND PULLED OUT OF THE PATIENT. A NEW SET WAS OPENED AND UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, NO REMNANTS OF THE DEVICE WAS LEFT IN THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 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

    IT WAS REPORTED THAT WHILE ACCESSING THE PATIENT'S ARTERY FOR A LOWER EXTREMITY ANGIOGRAM, ONCE THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET NEEDLE WAS INSIDE OF THE ARTERY, THE SET WIRE GUIDE WAS INSERTED. AS THE WIRE GUIDE WAS BEING MANIPULATED, THE TIP BROKE OFF INSIDE OF THE PATIENT'S ANATOMY. THE STIFFENED CANNULA INTRODUCER THAT GOES OVER THE WIRE GUIDE WAS INSERTED AND THE PHYSICIAN MADE A SKIN KNICK TO ADVANCE. DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE INTRODUCER AND IT BENT A FEW TIMES, BUT THE PHYSICIAN WAS ABLE TO ADVANCE IT. UPON REMOVAL OF THE INTRODUCER, THE TIP WAS WITHIN THE INTRODUCER; HOWEVER, WHEN THE INTRODUCER WAS PULLED OUT, THE TIP REMAINED INSIDE THE PATIENT ON THE NEEDLE TRACK. THE TIP WAS THEN ABLE TO BE GRABBED AND PULLED OUT OF THE PATIENT. A NEW SET WAS OPENED AND UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228701 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC 00827002355514

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention