BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 4212881 · Received October 30, 2014

    Report

    Report Number
    9681834-2014-00277
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 30, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - IS BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; UPON TESTING OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE CONCLUSIONS - IS BASED UPON EVALUATION OF USER FACILITY INFORMATION & THE RETURNED SAMPLE; IS BASED UPON TESTING OF UNDAMAGED SECTIONS OF THE RETURNED SAMPLE. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE URETHANE COAT WAS PEELED AND ROLLED BACK IN THE DISTAL DIRECTION OVER THE GLIDEWIRE APPROXIMATELY 122MM IN LENGTH. MAGNIFYING INSPECTION FOUND THE FOLLOWING CONDITIONS: (1) THE PROXIMAL END OF THE URETHANE COAT HAD BEEN SHIFTED FROM ITS ORIGINAL POSITION TO APPROXIMATELY 3MM FROM THE DISTAL END OF THE GLIDEWIRE; (2) THE ROLL BACK OF THE URETHANE COAT STARTED AT APPROXIMATELY 125MM FROM THE DISTAL END OF THE WIRE AND WAS TIGHTLY ROLLED WHICH MADE IT DIFFICULT TO REPLACE THE COAT IN ITS ORIGINAL POSITION AND TO MEASURE THE DIAMETER; (3) THE EVIDENCE THAT THE URETHANE COAT WAS AFFIXED TO THE SHAFT WAS FOUND AT APPROXIMATELY 249MM FROM THE DISTAL END OF THE WIRE; (4) A TRACE OF THE PROCESSING EDGE WAS FOUND AT THE PROXIMAL EXTREMITY OF THE URETHANE COAT WHICH CONFIRMED THAT THERE IS NO SEPARATED OR MISSING PORTION OF URETHANE COAT. THE UNDAMAGED SEGMENT OF GLIDEWIRE WAS INSPECTED BY INTENTIONALLY REMOVING THE URETHANE LAYER TO CHECK THE ADHESION STRENGTH AND NO ANOMALIES WERE FOUND, INCLUDING PEELING OR LIFTING OF THE URETHANE COAT. REPRODUCTIVE TESTING WAS THEN CONDUCTED USING A CURRENT PRODUCT RETENTION SAMPLE AND COMPETITOR'S CATHETER AND THE FOLLOWING TESTS WERE CONDUCTED: (1) THE COMPETITOR'S CATHETER WAS CURVED AND THEN THE RETENTION SAMPLE GLIDEWIRE WAS INSERTED AND ALLOWED TO COME IN CLOSE CONTACT WITH THE DISTAL EDGE OF THE CATHETER AND THEN WITHDRAWN. THE URETHANE COAT WAS NOT DAMAGED. (2) THE RETENTION GLIDEWIRE WAS INSERTED INTO THE COMPETITOR'S CATHETER AND ABRADED ON THE PROXIMAL END AND ALLOWED TO COME INTO CLOSE CONTACT WITH THE DISTAL EDGE OF THE CATHETER AND THEN WITHDRAWN. THE RESULTS SHOWED SIMILAR DAMAGE TO THAT OF THE ACTUAL SAMPLE - THE URETHANE COAT WAS PEELING OFF. (3) THE SAMPLE COMPETITOR'S CATHETER WAS ADVANCED OVER THE GLIDEWIRE IN A CURVED SEGMENT WHICH INCLUDED THE PROXIMAL END OF THE URETHANE COAT. THE DISTAL TIP OF THE COMPETITOR'S BALLOON CATHETER ACCIDENTALLY CAUGHT ON THE PROXIMAL END OF THE SAMPLE GLIDEWIRE'S URETHANE COAT. THE GLIDEWIRE WAS FORCEFULLY PUSHED WHICH EXCEEDED THE STRENGTH LIMIT OF THE DEVICE CAUSING THE URETHANE COAT TO PEEL OFF IN THE DISTAL DIRECTION. A REVIEW OF THE DEVICE HISTORY AND SHIPPING INSPECTION RECORDS CONFIRMED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS FOR THIS LOT NUMBER. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. BASED ON INVESTIGATION FINDINGS, THERE IS NO INDICATION THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE FINDINGS SUGGEST THAT THE GLIDEWIRE WAS SUBJECTED TO AN EXTERNAL FORCE WHICH EXCEEDED THE STRENGTH LIMIT OF THIS PRODUCT AT THE PROXIMAL END OF THE URETHANE COAT CAUSING IT TO PEEL BACK AND ROLL OVER THE SHAFT IN THE DISTAL DIRECTION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE COATING SHEARED ON A RADIFOCUS GLIDEWIRE ADVANTAGE (0.035" 180CM) DURING A PROCEDURE WHERE A 4FR CATHETER AND A 5FR GUIDING SHEATH WERE USED CONCOMITANTLY. IT WAS REPORTED THAT A METAL NEEDLE WAS NOT USED WITH THE GLIDEWIRE; HOWEVER THIS COULD NOT BE CONFIRMED. IT WAS ALSO REPORTED THAT THERE WAS NO HARM TO THE PATIENT, BUT NO ADDITIONAL EVENT DETAILS WERE PROVIDED BY THE USER FACILITY. THE SHEARED COATING OCCURRED ON TWO (2) OF THE SAME PRODUCTS IN SUCCESSION. THE OTHER EVENT IS REPORTED IN MDR NUMBER 9681834-2014-00278.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695389 RADIFOCUS GLIDEWIRE ADVANTAGE GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA N/A 140213

    Patients

    Seq Age Sex Outcome Treatment
    1 DESTINATION 5FR GUIDING SHEATH (TERUMO)| 4FR CATHETER (J&J)