BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 8248031 · Received January 15, 2019

    Report

    Report Number
    9681834-2018-00237
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    December 6, 2018
    Report Date
    January 15, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K122590 AND K163004 THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE INVOLVED OPTIMED SUPERFLEX STENT AND THE CD-ROM FROM THE INVOLVED PROCEDURE WAS ALSO RECEIVED. VISUAL INSPECTION REVEALED THAT THE URETHANE OUTER LAYER HAD BEEN ROLLED BACK OVER THE WIRE IN THE DISTAL DIRECTION. CLOSER VISUAL AND MAGNIFYING INSPECTIONS OBTAINED THE FINDINGS AS FOLLOWS; THE PROXIMAL END OF THE URETHANE OUTER LAYER WAS LOCATED AT THE DISTAL END OF THE DEVICE, AND THERE WAS A BUMP AT APPROXIMATELY 222MM FROM THE DISTAL END OF THE DEVICE WHERE THE PROXIMAL END OF THE URETHANE OUTER LAYER WAS LOCATED. THIS IMPLIED THE ORIGINAL DISTAL END OF THE GUIDEWIRE WAS LOCATED AT THIS POINT. THE ROLLBACK OF THE URETHANE OUTER LAYER HAD STARTED AT APPROXIMATELY 235MM FROM THE DISTAL END OF THE DEVICE WHERE THE PROXIMAL END OF THE URETHANE OUTER LAYER WAS LOCATED. THE METAL PART WAS NOTED AT APPROXIMATELY 470MM FROM THE DISTAL END OF THE DEVICE WHERE THE PROXIMAL END OF THE URETHANE OUTER LAYER WAS LOCATED, WHICH IS THE POINT WHERE THE PROXIMAL END OF THE URETHANE OUTER LAYER SHOULD BE ORIGINALLY LOCATED ON A NORMAL PRODUCT. THERE WAS NO LIFTING, GAP OR BREAK ON AND AROUND THE METAL PART. AN ATTEMPT TO RELEASE THE ROLLBACK OF THE URETHANE OUTER LAYER BACK IN THE PROXIMAL DIRECTION WAS FAILED. THE OVERLAPPED URETHANE OUTER LAYERS WERE FOUND TO HAVE STUCK TO EACH OTHER AND WOULD NOT GET SEPARATED FROM EACH OTHER. THIS PREVENTED THE OUTSIDE DIAMETER OF THE URETHANE LAYERED SECTION OF DEVICE FROM BEING INSPECTED. INSPECTION OF THE COMPETITOR'S DEVICE WAS PERFORMED. VISUAL INSPECTION REVEALED THAT THE CATHETER SHAFT HAD BEEN CRUSHED AT APPROXIMATELY 510MM FROM THE DISTAL END OF THE DEVICE. THE INSIDE DIAMETER WAS CONFIRMED TO BE WITHIN THE SCOPE APPLICABLE TO THE SIZE OF THE ACTUAL GUIDE WIRE SAMPLE. A RETENTION SAMPLE OF RA*FA18301CM WAS INSERTED IN THE COMPETITOR'S DEVICE FROM ITS HUB SIDE. THE RETENTION SAMPLE WAS FOUND TO BE ABLE TO BE ADVANCED ALL THE WAY THROUGH THE COMPETITOR'S DEVICE WITH SOME RESISTANCE FELT WHEN IT WAS PASSING THROUGH THE CRUSHED SECTION OF THE COMPETITOR'S DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULT, IT IS LIKELY THAT THE ACTUAL SAMPLE BECAME STUCK IN THE COMPETITOR'S DEVICE. DURING FOLLOWING MANIPULATIONS TO RELEASE THE STICKING OF THE DEVICES THE URETHANE OUTER LAYER OF THE ACTUAL SAMPLE GOT DAMAGED AND CURLED OUTWARD. FURTHER MANIPULATIONS TO RELEASE THE ACTUAL SAMPLE LED THE CURLED URETHANE OUTER LAYER TO GET PEELED AND ROLL BACK OVER THE WIRE. HOWEVER, WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OF ROTATE THE GLIDEWIRE ADVANTAGE OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. 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 THAT DURING A SFA INTERVENTION, THE RADIFOCUS GLIDEWIRE ADVANTAGE WIRE BECAME STUCK INTO THE WIRE LUMEN OF AN OPTIMED SINUS SUPERFLEX STENT. THE PHYSICIAN HAD TO WITHDRAW THE WIRE AND STENT. THERE WAS NO HARM TO THE PATIENT, AND THEY WERE TREATED AS INTENDED. ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 17, 2018. THE EVENT SIGNIFICANTLY DELAYED THE PROCEDURE. THE ACTUAL SAMPLE AND THE INVOLVED STENT WERE CHANGED OUT TO V18 AND EVERFLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41041 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 180625

    Patients

    Seq Age Sex Outcome Treatment
    1 OPTIMED SINUS 418| SUPERFLEX STENT 5.0-60