BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 3931595 · Received July 14, 2014

    Report

    Report Number
    9681834-2014-00190
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 14, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RETURNED & EVALUATED BY QA AT THE MANUFACTURING FACILITY. VISUAL INSPECTION FOUND THAT THE URETHANE COAT HAD BEEN ROLLED BACK OVER THE WIRE 117MM IN LENGTH IN THE DISTAL DIRECTION. UNDER MAGNIFYING INSPECTION THE FOLLOWING WAS NOTED: THE PROXIMAL END OF THE URETHANE COAT WAS LOCATED AT APPROXIMATELY 8MM FROM THE DISTAL END OF THE DEVICE; THE ROLL-BACK OF THE URETHANE COAT STARTED AT APPROXIMATELY 125MM FROM THE DISTAL END OF THE SHAFT, THE EVIDENCE OF THE URETHANE COAT HAVING BEEN FIXED ON THE SHAFT WAS FOUND AT APPROXIMATELY 246MM FROM THE DISTAL END OF THE SHAFT; THE TRACE OF THE PROCESSING OF THE PROXIMAL END OF THE URETHANE COAT WAS FOUND IN PLACE ON THE SHAFT, THIS DEMONSTRATED THAT THERE WAS NO MISSING PORTION 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 IMPOSSIBLE TO RELEASE THE ROLLED URETHANE COAT BACK TO THE ORIGINAL POSITION. THE OUTER DIAMETER OF THE URETHANE COAT WAS MEASURED ON THE INTACT SEGMENT AND CONFIRMED TO MEET THE SPECIFICATIONS, BEING COMPARABLE TO THAT OF THE CURRENT PRODUCT SAMPLE. THE URETHANE COAT ON THE INTACT SEGMENT WAS REMOVED INTENTIONALLY TO CHECK THE LEVEL OF ADHESION OF THE URETHANE COAT TO THE CORE WIRE. THERE WERE NOT ANY ANOMALIES, WITH NO PEELED OR LIFTED PORTION. REPRODUCTIVE TESTING WAS CONDUCTED. IT'S WAS NOTED THAT A CURVATURE WAS GIVEN TO THE COMPETITOR'S CATHETER, IN WHICH THE GUIDE WIRE WAS INSERTED. SUBSEQUENTLY, THE GUIDE WIRE WAS LET TO COME CLOSE CONTACT WITH THE DISTAL EDGE OF THE CATHETER AND IN THIS STATE; THE GUIDE WIRE WAS WITHDRAWN FROM THE CATHETER. THE URETHANE COAT DID NOT GET PEELED OFF. THE GUIDE WIRE WAS INSERTED INTO A COMPETITOR'S CATHETER AND THEN AN ABRASION WAS GIVEN TO THE PROXIMAL END OF THE URETHANE COAT ON THE GUIDE WIRE. SUBSEQUENTLY THE GUIDE WIRE WAS LET TO COME CLOSE CONTACT WITH THE DISTAL EDGE OF THE CATHETER AND IN THIS STATE; THE GUIDE WIRE WAS WITHDRAWN FROM THE CATHETER. THE URETHANE COAT GOT DAMAGED IN THE MANNER SIMILAR TO THE ACTUAL SAMPLE WITH PEEL-OFF OF THE URETHANE COAT. THE DISTAL TIP OF THE COMPETITOR'S BALLOON CATHETER MAY ACCIDENTALLY CATCH THIS PRODUCT AT THE TRANSITION OF THE URETHANE OUTER LAYER WHEN THE CATHETER IS ADVANCED OVER THE WIRE IN THE STATE WHERE THE WIRE IS CURVED ON THE AREA THE TRANSITION OF THE URETHANE OUTER LAYER IS INCLUDED. 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 BASED UPON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION AND APPEARANCE OF THE RETURNED SAMPLE ALONG WITH CONFIRMATION BY SIMULATION TESTING ARE MOST CONSISTENT WITH THE ACTUAL DEVICE BEING SUBJECTED TO AN EXTERNAL FORCE WHICH EXCEEDED THE STRENGTH LIMIT OF THIS PRODUCT AT THE PROXIMAL END OF THE URETHANE COAT. SUBSEQUENTLY THE ACTUAL SAMPLE HAD CONTACT WITH THE DEVICE USED IN COMBINATION WITH IT, RESULTING IN THE GENERATION OF THE ROLLBACK IN THE URETHANE COAT. 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." 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 THE TIP BUBBLES OUT AND IS LARGER THAN WHAT IT SHOULD BE ON THE DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THAT THE ISSUE WAS NOTICED PRIOR TO BEING USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409874 RADIFOCUS GLIDEWIRE ADVANTAGE GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA 140213

    Patients

    Seq Age Sex Outcome Treatment
    1