BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M

    MDR report key: 7303120 · Received February 28, 2018

    Report

    Report Number
    9681834-2018-00022
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 5, 2018
    Report Date
    February 28, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K923607 AND K926214 THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE URETHANE OUTER LAYER HAD BEEN SHEARED OFF ON APPROXIMATELY 30MM - 210MM FROM THE DISTAL END OF THE DEVICE. MAGNIFYING INSPECTION OF THE URETHANE OUTER LAYER OF THE SHEARED SEGMENT REVEALED THE FOLLOWING: ON APPROXIMATELY 30MM - 178MM FROM THE DISTAL END OF THE DEVICE, THE URETHANE OUTER LAYER HAD BEEN SHEARED OFF THE WIRE WITH NO EXPOSURE OF THE CORE WIRE. ON APPROXIMATELY 180MM - 185MM FROM THE DISTAL END OF THE DEVICE, THE URETHANE OUTER LAYER HAD BEEN SHEARED OFF THE WIRE IN THE DISTAL DIRECTION, WITH THE SHEARED PORTION STILL REMAINING ON THE WIRE. ON APPROXIMATELY 187MM - 193MM AND APPROXIMATELY 208MM - 210MM FROM THE DISTAL END OF THE DEVICE, THE URETHANE OUTER LAYER HAD BEEN SEMI-CIRCUMFERENTIALLY SHEARED OFF THE WIRE WHERE THE CORE WIRE WAS EXPOSED, AND THE SHEAR CROSS-SECTION OF THE URETHANE OUTER LAYER WAS IN THE SMOOTH STATE. FROM THESE FINDINGS, IT IS LIKELY THAT THE URETHANE OUTER LAYER GOT SHEARED OFF IN THE DISTAL DIRECTION WHEN THE ACTUAL SAMPLE CAME INTO CONTACT WITH A SHARP OBJECT. THE OUTSIDE DIAMETER WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET THE SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED, BASED ON THE LIKELINESS THAT THE ACTUAL SAMPLE HAD BEEN USED IN COMBINATION WITH A METALLIC DEVICE, INCLUDING A METALLIC NEEDLE. A CURRENT GUIDEWIRE M PRODUCT SAMPLE WAS INSERTED INTO A METALLIC NEEDLE AND WITHDRAWN THROUGH IT IN THE MANNER OF THE GUIDEWIRE M SAMPLE HAVING CONTACT WITH THE METALLIC NEEDLE. THE URETHANE COATING WAS SEMI-CIRCUMFERENTIALLY SHEARED OFF THE WIRE WHERE THE CORE WIRE WAS EXPOSED. THE SURFACE OF THE SHEAR CROSS-SECTION OF THE URETHANE OUTER LAYER WAS NOTED TO BE IN THE SMOOTH STATE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD FROM THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTION-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: "DO NOT USE THE GUIDEWIRE M WITH DEVICES WHICH CONTAIN METAL PARTS SUCH AS ATHERECTOMY CATHETERS, LASER CATHETER, OR METAL INTRODUCTION DEVICES AS THEY MAY CAUSE THE GUIDEWIRE M PLASTIC COATING TO SHEAR AND/OR SEVER THE WIRE. DO NOT MANIPULATE OR WITHDRAW THE GUIDEWIRE M THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE GUIDEWIRE WAS INSERTED INTO AN INITIAL PUNCTURE NEEDLE. UPON REMOVAL FROM THE PATIENT, THE SCRUB NURSE OBSERVED THAT PART OF THE COATING WAS PEELING OFF FROM THE GUIDEWIRE SHAFT. A NEW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. AN 18G/20CM INITIAL PUNCTURE NEEDLE WAS USED WITH THE PRODUCT. THERE WAS NO IMMEDIATE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146314 RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M GUIDEWIRE CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 160314

    Patients

    Seq Age Sex Outcome Treatment
    1