BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD

    MDR report key: 2882978 · Received December 19, 2012

    Report

    Report Number
    2882978
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 14, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRE ADVANCED INTO RADIAL ARTERY WHEN THE WIRE MALFUNCTIONED. UNABLE TOREMOVE AND PATIENT WAS TAKEN TO OR FOR REMOVAL. IT IS QUESTIONED IF "J" TIP DID NOT STRAIGHTEN OUT WHEN PULLED.DESCRIPTION OF PROCEDURE: THE PATIENT IS PREPPED AND DRAPED IN STERILE FASHION. INFORMED CONSENT WAS OBTAINED. A 5 FRENCH SHEATH WAS INSERTED IN THE RIGHT RADIAL ARTERY USING SELDINGER TECHNIQUE WITHOUT DIFFICULTY. A 5 FRENCH J WIRE WAS ADVANCED THROUGH THE SHEATH AND MET RESISTANCE IN THE BRACHIAL ARTERY. GUIDEWIRE DID NOT WITHDRAW. THERE WAS SIGNIFICANT RESISTANCE AT THE ELBOW. A 6 FRENCH SHEATH WAS INSERTED IN THE RIGHT COMMON FEMORAL ARTERY USING MODIFIED SELDINGER TECHNIQUE. LEFT CORONARY ANGIOGRAPHY WAS PERFORMED WITH A 6 FRENCH LEFT JUDKINS 4 CM DIAGNOSTIC CATHETER. RIGHT CORONARY ANGIOGRAPHY WAS PERFORMED WITH A 6 FRENCH (DICTATION ANOMALY) PLUS 1 DIAGNOSTIC CATHETER. ALL CATHETER EXCHANGES WERE PERFORMED OVER GUIDEWIRE. ANGIOGRAM WAS PERFORMED THROUGH THE RIGHT COMMON FEMORAL SHEATH. STARCLOSE DEPLOYED TO THE RIGHT COMMON FEMORAL ARTERY WITH GOOD HEMOSTASIS. THE WIRE IN THE RIGHT RADIAL ARTERY WAS SECURED IN PLACE. SURGERY WAS CONSULTED TO REMOVE SURGICALLY. THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. RECOMMENDATIONS: 1) SURGICAL REMOVAL OF J WIRE FROM THE RIGHT RADIAL ARTERY, SUSPECT FAULTY J TIP OF THE GUIDEWIRE WHICH WILL BE INSPECTED DURING SURGERY. 2) STAGED INTERVENTION OF RIGHT CORONARY ARTERY.-------------------------------------------------------------------OPERATIVE PROCEDURE: PATIENT WAS BROUGHT TO THE OPERATING ROOM AND AFTER IV SEDATION WAS GIVEN, THE PATIENT'S RIGHT UPPER EXTREMITY WAS PREPPED AND DRAPED USING ALL ASEPTIC PRECAUTIONS. THE SMALL INCISION, APPROXIMATELY 3 CM LONG, WAS MADE A FINGERBREADTH BELOW THE PATIENT'S RIGHT ELBOW CREASE AREA TRANSVERSELY. THE SKIN AND SUBCUTANEOUS TISSUES WERE DIVIDED. THE BRACHIAL APONEUROSIS WAS DIVIDED. THE PATIENT'S BRACHIAL ARTERY WAS IDENTIFIED. RADIAL ARTERY WAS IDENTIFIED AND THE WIRETHAT WAS COMING OUT THROUGH ONE OF THE BRANCHES OF THE RADIAL ARTERY WAS IDENTIFIED. THE ARTERY WAS EXPOSED FURTHER AND THE SMALL INCISION WAS MADE OVERLYING THIS BRANCH, ALLOWING THE WIRE TO GET HOLD OF AND THEN THE WIRE WAS FREED FROM THE ARTERIAL BRANCH COMPLETELY AND THEN IT WAS EASILY PULLED OUT BY RELEASING THE CLAMP IN THE WRIST AREA, AND THE WIRE WAS PULLED OUT FROM THIS INCISION ABOVE. THE ARTERIAL BRANCH WAS A SMALL BRANCH AND WAS LIGATED USING 3-0 SILK SUTURES. THE WOUND WAS IRRIGATED.PATIENT DID NOT HAVE ANY BLEEDING. THE WOUND WAS CLOSED USING 3-0 SUTURE FOR THE FASCIA AND SUBCUTANEOUS TISSUE, AND THE SKIN WAS CLOSED USING SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERALD CATHETER DQX CORDIS CORPORATION * F0912121

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR