BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERALD DIAGNOSTIC GUIDEWIRES

    MDR report key: 2924629 · Received January 22, 2013

    Report

    Report Number
    1016427-2013-00009
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA VOLUNTARY MEDWATCH, AN EMERALD J WIRE WAS ADVANCED INTO RADIAL ARTERY WHEN THE WIRE MALFUNCTIONED. THE PHYSICIAN WAS UNABLE TO REMOVE THE WIRE FROM THE VESSEL. THEREFORE, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL. IT IS QUESTIONED IF "J TIP DID NOT STRAIGHTEN OUT WHEN PULLED. 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 EMERALD J WIRE WAS ADVANCED THROUGH THE SHEATH AND MET RESISTANCE IN THE BRACHIAL ARTERY. THE GUIDEWIRE DID NOT WITHDRAW. THERE WAS SIGNIFICANT RESISTANCE AT THE ELBOW. THEREFORE, A 6 FRENCH SHEATH WAS INSERTED IN THE RIGHT COMMON FEMORAL ARTERY AND THE CORONARY INTERVENTION WAS SUCCESSFULLY COMPLETED. THE WIRE IN THE RIGHT RADIAL ARTERY WAS SECURED IN PLACE. SURGERY WAS CONSULTED TO REMOVE SURGICALLY. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REMOVAL OF THE EMERALD WIRE. A 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. THE RADIAL ARTERY WAS IDENTIFIED AND THE WIRE THAT 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. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. WIRE ENTRAPMENT IN THE VASCULATURE HAS BEEN REPORTED IN PROCEDURES INVOLVING TOTAL OCCLUSIONS, HIGHLY TORTUOUS VASCULATURE, AND SMALL SIDE BRANCHES. THE IFU INDICATES IN THE PRECAUTIONS SECTIONS THAT IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER AND GUIDEWIRE. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (ENTRAPPED IN A SMALL BRANCH OF THE RADIAL ARTERY) THAT MAY HAVE CONTRIBUTED TO THE EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED VIA VOLUNTARY MEDWATCH, AN EMERALD J WIRE WAS ADVANCED INTO RADIAL ARTERY WHEN THE WIRE MALFUNCTIONED. THE PHYSICIAN WAS UNABLE TO REMOVE THE WIRE FROM THE VESSEL. THEREFORE THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL. IT IS QUESTIONED IF "J" TIP DID NOT STRAIGHTEN OUT WHEN PULLED. 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 EMERALD J WIRE WAS ADVANCED THROUGH THE SHEATH AND MET RESISTANCE IN THE BRACHIAL ARTERY. THE GUIDEWIRE DID NOT WITHDRAW. THERE WAS SIGNIFICANT RESISTANCE AT THE ELBOW. THEREFORE A 6 FRENCH SHEATH WAS INSERTED IN THE RIGHT COMMON FEMORAL ARTERY AND THE CORONARY INTERVENTION WAS SUCCESSFULLY COMPLETED. THE WIRE IN THE RIGHT RADIAL ARTERY WAS SECURED IN PLACE. SURGERY WAS CONSULTED TO REMOVE SURGICALLY. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REMOVAL OF THE EMERALD WIRE. A SMALL INCISION, APPROXIMATELY 3 CM LONG, WAS MADE A FINGER BREADTH 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. THE RADIAL ARTERY WAS IDENTIFIED AND THE WIRE THAT 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
    29951 EMERALD DIAGNOSTIC GUIDEWIRES CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R