BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 8484651 · Received April 4, 2019

    Report

    Report Number
    9681834-2019-00046
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 4, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. VISUAL INSPECTION UPON RECEIPT FOUND THE ACTUAL SAMPLE WAS IN THE STATE OF BEING INSERTED IN A COMPETITOR'S CATHETER. THE ACTUAL SAMPLE WAS REMOVED FROM THE COMPETITOR'S CATHETER AND INSPECTED WITH THE NAKED EYE, AND THEN, UNDER MAGNIFICATION AND ELECTRIC MICROSCOPY. THE FOLLOWING FINDINGS WERE OBTAINED. THE URETHANE OUTER LAYER HAD BEEN DAMAGED ON APPROX. 210-240MM FROM THE DISTAL END OF THE DEVICE, WHERE IT HAD BEEN RIPPED, PARTIALLY PEELING OFF THE CORE WIRE, PARTIALLY SHEARED OFF THE CORE WIRE AND PARTIALLY ABRADED ON ITS SURFACE. AROUND THE DISTAL END OF THE DAMAGED SECTION, THE URETHANE OUTER LAYER HAD BEEN BUCKLED. THE OUTSIDE DIAMETER OF THE URETHANE OUTER LAYER ON THE UNDAMAGED SECTION WAS CONFIRMED TO MEET THE SPECIFICATIONS. THE COMPETITOR'S DEVICE WAS EVALUATED. VISUAL AND MAGNIFYING INSPECTION REVEALED THE FOLLOWING FINDINGS. THE SECTION AROUND 65MM FROM THE DISTAL END OF THE DEVICE HAD BEEN DEFORMED. SOME ABRASIONS HAD BEEN GENERATED ON THE SHAFT, INCLUDING THE DISTAL END OF THE SHAFT. 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 DISTAL SECTION OF THE ACTUAL SAMPLE CAME INTO CONTACT WITH SOME HARD OBJECT, INCLUDING A STENOSED SEGMENT IN THE LESION, WHERE THE URETHANE OUTER LAYER GOT BROKEN AND CURLED OUTWARD/INWARD. SUBSEQUENTLY, WHEN THE ACTUAL SAMPLE WAS WITHDRAWN, THE DISTAL EDGE OF THE COMPETITOR'S CATHETER GOT CAUGHT IN THE CURLED PORTION OF THE URETHANE OUTER LAYER. FURTHER WITHDRAWAL OF THE ACTUAL SAMPLE IN THIS STATE CONTRIBUTED TO FURTHER CURLING ON THE URETHANE OUTER LAYER OF THE ACTUAL SAMPLE, RESULTING IN THE DAMAGE FOUND. HOWEVER, 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 OR 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 THE RADIFOCUS GLIDEWIRE ADVANTAGE WIRE COULD NOT BE PULLED OUT OF THE CATHETER. THE REASON FOR THIS WAS THAT THE COATING ON THE DISTAL PART (THE PART OF THE WIRE MADE FROM OUR STANDARD WIRE) HAS PEELED OFF AND SLID OFF. THE WIRE COULD ONLY BE PULLED OUT TOGETHER WITH THE CATHETER. BOTH MATERIALS COULD BE REMOVED OUT OF THE PATIENT. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277135 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 180619

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER