BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 4203802 · Received October 27, 2014

    Report

    Report Number
    9681834-2014-00274
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 27, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. A PIECE OF URETHANE COAT WHICH SEEMS TO HAVE BEEN SEPARATED FROM THE ACTUAL SAMPLE WAS RETURNED ALONG WITH THE ACTUAL SAMPLE. INSPECTION UPON RECEIPT FOUND THAT THE ACTUAL SAMPLE HAD BEEN SHEARED OFF THE URETHANE COAT ON THE SEGMENT ON APPROXIMATELY 1MM-232MM FROM THE DISTAL END OF THE SHAFT, APPROXIMATELY 141MM IN LENGTH, EXPOSING THE CORE WIRE. THE PIECE OF URETHANE COAT MEASURED APPROXIMATELY 138MM. MAGNIFYING INSPECTION OF THE SHEARED SEGMENT ON APPROXIMATELY 91MM-232MM FROM THE DISTAL END OF THE SHAFT FOUND THAT THE SHEAR CROSS-SECTION SURFACE OF THE URETHANE LAYER HAD A SMOOTH SURFACE. FURTHER INSPECTION FOUND THE PRESENCE OF INTERMITTENT ABRASIONS ON THE SEGMENT FROM THE DISTAL END TO APPROXIMATELY 232MM TO THE PROXIMAL, WHERE IT WAS FOUND THAT THE CHARACTERISTIC GLOSS A NORMAL GLIDE WIRE PRESENTS HAD BEEN DISAPPEARED. MAGNIFYING INSPECTION OF THE URETHANE PIECE FOUND THAT THE SHEARED CROSS-SECTION SURFACE WAS IN THE SMOOTH STATE, WITH ONE END HAVING BEEN ELONGATED. THE OUTSIDE DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO BE NORMAL WITHIN THE SPECIFICATIONS. THE ACTUAL SAMPLE WAS PEELED OFF THE URETHANE LAYER FROM THE WIRE INTENTIONALLY IN ORDER TO CHECK THE ADHESION LEVEL OF THE URETHANE LAYER TO THE CORE WIRE. THERE WAS NO LIFTING OR GAP BETWEEN THE CORE WIRE AND THE URETHANE OUTER LAYER. THIS IMPLIES THAT THE ACTUAL SAMPLE HAD NO INHERENT ANOMALY IN THE STATE OF ADHESION OF THE URETHANE COATING TO THE CORE WIRE. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING RECORD CONFIRMED THERE WAS NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, THE APPEARANCE OF THE INVOLVED SAMPLE IS MOST CONSISTENT WITH THE ACTUAL SAMPLE BEING PULLED THROUGH THE INVOLVED METAL NEEDLE IN THE PROXIMAL DIRECTION IN THE STATE OF HAVING CONTACT WITH THE EDGE OF THE METAL NEEDLE, RESULTING IN THE SHEARING OF THE URETHANE LAYER. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE INSTRUCTIONS-FOR-USE. THE IFU STATES: "DO NOT USE THE GUIDE WIRE M WITH DEVICES WHICH CONTAIN METAL PARTS SUCH AS ATHERECTOMY CATHETERS, LASER CATHETER, OR METAL INTRODUCTION DEVICES AS THEY MAY CAUSE THE GUIDE WIRE M PLASTIC COATING TO SHEAR AND/OR SEVER THE WIRE." A COMBINATION USE OF THIS PRODUCT WITH A METAL DEVICE, INCLUDING A METALLIC NEEDLE AND A METALLIC CANNULA, SHOULD BE AVOIDED AS THE URETHANE LAYER ON THE SURFACE OF THE GUIDE WIRE COULD BE SHEARED OFF WITH SUCH METALLIC DEVICES. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE AFTER REMOVING THE GLIDEWIRE THE END WAS NOTED TO BE SHREDDED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING: (1) INSERTION OF LEFT SUBCLAVIAN VEIN POWER P.A.C. PORT-A-CATH VIA FLUOROSCOPY GUIDANCE WAS THE PROCEDURE BEING CONDUCTED; (2) A 22-GAUGE NEEDLE AND SYRINGE FROM LARGE BORE NEEDLE WERE REMOVED AND GUIDEWIRE WAS INSERTED THROUGH THE NEEDLE AND INTO THE VEIN; (3) THE GUIDEWIRE WOULD NOT FLOAT, AND WAS REMOVED; (4) AN 80CM GLIDEWIRE WAS INSERTED THROUGH THE NEEDLE AND INTO THE VEIN; (5) THE SURGEON PLACED THE GLIDEWIRE THROUGH AN 18G NEEDLE; (6) ONCE THE GUIDEWIRE WAS IN POSITION, IT WAS VIEWED WITH FLUOROSCOPY; (7) THE GUIDEWIRE WOULD NOT FLOAT DOWN TO THE SUBCLAVIAN AND INTO THE SUPERIOR VENA CAVA, BUT RATHER HAD FLOATED DOWN INTO THE PATIENT'S LEFT ARM; (8) THE WIRE WAS REMOVED; (9) SEVERAL MORE ATTEMPTS TO FLOAT THE GUIDEWIRE TO THE SUBCLAVIAN AND INTO THE SUPERIOR VENA CAVA WAS UNSUCCESSFUL; (10) WHEN THE GUIDEWIRE WAS REMOVED THE LAST TIME THE TEFLON COATING HAD SPLINTERED OFF THE DISTAL END OF THE WIRE;(11) THE SURGEON CONFIRMED NO FOREIGN BODY WAS DETECTED; (12) ATTEMPTS AT THE LEFT INTERNAL JUGULAR VEIN APPROACH WERE ABORTED AND THE SURGEON USED THE LEFT SUBCLAVIAN VEIN APPROACH; (13) THE PATIENT WAS REPORTED TO TOLERATE THE PROCEDURE WELL WITH NO OTHER REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683586 RADIFOCUS GLIDEWIRE GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 140409

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 18G NEEDLE AND/OR 22G NEEDLE