BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 3781268 · Received April 30, 2014

    Report

    Report Number
    9681834-2014-00107
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 30, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS CONDUCTED BASED ON A REVIEW OF INFORMATION PROVIDED BY THE USER FACILITY, RETAINED SAMPLES AND MANUFACTURING QUALITY RECORDS. INSPECTION AND TESTING OF RETAINED SAMPLES FROM THE REPORTED LOT CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. 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. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED, THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A DEFECT OR MALFUNCTION OF THE DEVICE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IN (B)(4). VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE URETHANE COAT WAS NOTED TO HAVE BEEN PEELED AND ROLLED BACK IN THE DISTAL DIRECTION OVER THE WIRE. THE PROXIMAL END OF THE URETHANE COAT HAD BEEN SHIFTED FROM ITS ORIGINAL POSITION TO THE DISTAL EXTREMITY OF THE DEVICE. A BULGE WAS NOTED AT APPROXIMATELY 12MM FROM THE DISTAL END OF THE DEVICE. THIS BULGE MAY BE THE ORIGINAL DISTAL END OF THE GUIDE WIRE SHAFT. THE ROLL BACK OF THE URETHANE COAT STARTED APPROXIMATELY 132MM FROM THE DISTAL END OF THE DEVICE. THE EVIDENCE OF THE URETHANE COAT HAVING BEEN FIXED ON THE SHAFT WAS FOUND ON THE SHAFT AT APPROXIMATELY 255MM FROM THE DISTAL END OF THE DEVICE. MAGNIFYING INSPECTION OF THE PROXIMAL END OF THE URETHANE COAT FOUND THAT THE EDGE WAS THINNER THAN OTHER PORTION, IMPLYING THAT THE PROPER PROCESSING HAD BEEN APPLIED TO THE EDGE OF THE URETHANE COAT. THE PORTION OF THE URETHANE COAT ROLLED BACK OVER THE WIRE WAS FOUND TO BE ADHERING TO THE URETHANE COAT UNDER THE ROLLED PORTION SO TIGHT THAT IT WAS VERY DIFFICULT TO GET IT BACK TO THE ORIGINAL POSITION. THE OUTSIDE DIAMETER OF THE URETHANE COATED SEGMENT WAS, THEREFORE, UNABLE TO BE DETERMINED. THE URETHANE COATING WAS REMOVED INTENTIONALLY TO CHECK THE ADHESION LEVEL OF THE URETHANE COAT TO THE CORE WIRE. THERE WERE NOT ANY ANOMALIES. A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FROM THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT HAS NOT BEEN REPORTED PREVIOUSLY. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION IS CONSISTENT WITH THE ACTUAL SAMPLE BEING SUBJECTED TO AN EXTERNAL FORCE WHICH EXCEEDED THE STRENGTH LIMIT OF THIS PRODUCT AT THE PROXIMAL END OF THE URETHANE COAT AND THE URETHANE COAT WAS PEELED BACK OVER THE SHAFT IN THE DISTAL DIRECTION. THE PEELED URETHANE COAT ADHERED TO THE LUMEN OF THE INVOLVED COMPETITOR'S CATHETER, RESULTING IN THE REPORTED DIFFICULTY IN REMOVING THE ACTUAL SAMPLE FROM THE COMPETITOR'S CATHETER. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT WITH STATEMENTS IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE THAT INAPPROPRIATE MANIPULATION OF THE GLIDEWIRE UNDER CERTAIN CONDITIONS MAY RESULT IN "SHEARING OF THE GLIDEWIRE ADVANTAGE, DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL." IN ADDITION, THE IFU STATES, "WHEN USING A DRUG OR A DEVICE CONCURRENTLY WITH THE GLIDEWIRE ADVANTAGE, THE OPERATOR SHOULD HAVE A FULL UNDERSTANDING OF THE PROPERTIES/CHARACTERISTICS OF THE DRUG OR DEVICE SO AS TO AVOID DAMAGE TO THE GLIDEWIRE ADVANTAGE." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED FEELING RESISTANCE WHEN PULLING BACK ON THE GWA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE DOCTOR SELECTED SUCCESSFULLY THE LEFT ILIAC SYSTEM FROM THE RIGHT FEMORAL ARTERY (UP AND OVER AORTIC BIFURCATION); A ANGIODYNAMICS OMNI SOS CATHETER WAS TRACKED OVER THE GWA WITH NO PROBLEMS TO BE IN POSITION TO TAKE A ANGIOGRAM OF THE LEFT ILIAC AND LOWER EXTREMITY ARTERIES; THE GWA WAS PULLED BACK OUT OF THE CATHETER, WHILE PULLING HALF WAY BACK THE DOCTOR FELT A LITTLE RESISTANCE; THE DOCTOR PULLED THE WIRE OUT OF THE CATHETER AND THE POLYURETHANE HYDROPHILIC JACKET OF THE WIRE WAS PULLED OFF; THE CATHETER AND WIRE WAS REMOVED FROM THE BODY AT THE SAME TIME AND NOTHING WAS LEFT IN THE BODY; THE WIRE WAS CHANGED OUT AND PROCEDURE COMPLETED; AND PATIENT IS REPORTED DOING "FINE."

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 9681834-2014-00107 TO PROVIDE ADDITIONAL INFORMATION REGARDING EVALUATION OF THE RETURNED SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259119 RADIFOCUS GLIDEWIRE ADVANTAGE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 130307

    Patients

    Seq Age Sex Outcome Treatment
    1 ANGIODYNAMICS 5FR. SOS OMNI DIAGNOSTIC CATHETER| PINNACLE 6FR. SHEATH 10CM