BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE V

    MDR report key: 4662112 · Received April 6, 2015

    Report

    Report Number
    9681834-2015-00053
    Event Type
    Injury
    Date Received
    April 6, 2015
    Date of Event
    May 30, 2014
    Report Date
    April 6, 2015
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS - IS BASED ON THE EVALUATION OF CURRENT PRODUCT SAMPLE DUE TO THE UNKNOWN PRODUCT CODE AND UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF THE MAUDE EVENT REPORT INFORMATION AND CURRENT PRODUCT SAMPLE ((B)(4), LOT # 150312). VISUAL INSPECTION OF THE SAMPLE DID NOT FIND ANY ANOMALY. MAGNIFYING INSPECTION DID NOT REVEAL ANY ANOMALIES. THE OUTSIDE DIAMETER ALONG THE TOTAL LENGTH WAS CONFIRMED TO BE WITHIN THE MANUFACTURING SPECIFICATIONS. THE SAMPLE WAS PEELED OF THE URETHANE OUTER LAYER FROM THE WIRE INTENTIONALLY FOR THE PURPOSE OF CHECKING THE ADHESION LEVEL OF THE URETHANE OUTER LAYER TO THE CORE WIRE. NO ANOMALIES WERE OBSERVED. THE PRODUCT CODE AND PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT FILES. 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, IT IS LIKELY A METAL NEEDLE OR A METAL DEVICE, INCLUDING AN ENDOSCOPE WAS USED IN COMBINATION WITH THE ACTUAL SAMPLE. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS THE FOLLOWING: "DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL ENTRY NEEDLE OR METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR 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." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A SEARCH OF THE FDA'S MAUDE DATABASE ON MARCH 13, 2015 FOUND MEDWATCH REPORT # MW5040848 THAT STATES THE FOLLOWING: (1) A FRAGMENT FROM THE OUTSIDE COATING OF THE GUIDEWIRE WAS FOUND IN THE PATIENT'S LEFT FEMORIS ARTERY. (2) THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL AND WAS NOTED IN CARDIOGENIC SHOCK AND VASODILATORY SHOCK; (3) SECONDARY TO A NON-SEGMENT ELEVATION MYOCARDIAL INFARCTION FOR WHICH HE RECEIVED A DRUG ELUDING STENT; (4) THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA WITH CARDIAC ARREST; THE PATIENT WAS RESUSCITATED AND ABLATION WAS PERFORMED WHICH WAS UNSUCCESSFUL; (5) THE PATIENT WAS TRANSFERRED FOR FURTHER MANAGEMENT; (6) THE PATIENT CONTINUED TO HAVE VENTRICULAR TACHYCARDIA; (7) VA-EMCO WAS INITIATED; (8) THE PATIENT HAD COMPLICATED CCU COURSE WHICH INCLUDED SUCCESSFUL VT ABLATION AND PNEUMONIA WHICH WAS TREATED WITH ANTIBIOTICS; (9) A CT REVEALED A RETROPERITONEAL BLEED WITH FINDINGS OF BILATERAL DEEP VEIN THROMBOSIS; (10) A FOREIGN OBJECT WAS ALSO NOTED IN LEFT PROFUNDA FEMORIS ARTERY ON THE CT SCAN WHICH WAS EVENTUALLY IDENTIFIED AS A FRAGMENT OF THE OUTSIDE COATING FROM A GUIDEWIRE KNOWN AS GLIDEWIRE; (11) THE PATIENT HAD THE RETAINED FOREIGN BODY REMOVED; AND (12) THE PATIENT WAS DISCHARGED HOME WITH NURSING AND PHYSICAL THERAPY SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226378 RADIFOCUS GLIDEWIRE V GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA N/A UKN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other