BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 9999964 · Received April 27, 2020

    Report

    Report Number
    9681834-2020-00068
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    April 7, 2020
    Report Date
    April 27, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K926214. (B)(4). THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE ACTUAL SAMPLE HAD BEEN CUT IN TWO PORTIONS. IT HAD BEEN CUT AT APPROXIMATELY 120MM FROM THE DISTAL END. TWO PORTIONS WERE MEASURED AND CONFIRMED TO BE 1500MM IN TOTAL LENGTH, WHICH WAS EQUIVALENT TO THAT OF A FACTORY-RETAINED SAMPLE OF THE INVOLVED PRODUCT CODE, OF WHICH LENGTH WAS 1500MM. BASED ON THIS RESULT, IT WAS LIKELY THAT THE ACTUAL SAMPLE HAD NO MISSING PORTION. THE DISTAL PORTION OF THE ACTUAL SAMPLE WAS INSPECTED VISUALLY WITH CCD AND SEM AND REVEALED THAT THE PROXIMAL END OF URETHANE COATING SEEMED TO HAVE BEEN PULLED AND TORN-OFF; THE CORE WIRE WAS EXPOSED. THE PROXIMAL PORTION OF THE ACTUAL SAMPLE WAS INSPECTED VISUALLY WITH CCD AND SEM. IT WAS REVEALED THAT THE URETHANE COATING HAD BEEN STRETCHED. THE CUT SURFACE (FRACTURE SURFACE) OF THE CORE WIRE OF BOTH PORTIONS WERE INSPECTED WITH SEM. RADIAL PATTERN WAS REVEALED ON BOTH SURFACES. NO TAPERED DEFORMATION WAS OBSERVED. THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET THE MANUFACTURER SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED, AND A PRODUCT SAMPLE IN A CURVED STATE WAS SUBJECTED TO CONSECUTIVE ONE-WAY TORQUE FORCE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION REVEALED THE FRACTURE END OF THE CORE WIRE WAS FLAT AND RADIAL PATTERN HAD BEEN GENERATED ON THE FRACTURE SURFACE. THE STATE WAS FOUND TO BE SIMILAR TO THAT ON THE ACTUAL SAMPLE. A PRODUCT SAMPLE WAS SUBJECTED TO REPETITIVE BENDING FORCE AT A 90-DEGREE ANGLE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION REVEALED THAT THE FRACTURE END WAS NOT CURVED, AND DIMPLES HAD BEEN GENERATED ON THE FRACTURE SURFACE. THE STATE WAS FOUND TO BE DIFFERENT FROM THAT ON THE ACTUAL SAMPLE. A PRODUCT SAMPLE HOLD IN A LOOP SHAPE WAS SUBJECTED TO PULLING FORCE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION REVEALED THE FRACTURE END HAD BEEN CURVED. THE FRACTURE SURFACE WAS IN A ROUGH STATE. THE STATE WAS FOUND TO BE DIFFERENT FROM THAT ON THE ACTUAL SAMPLE. A PRODUCT SAMPLE WAS SUBJECTED TO ONE-WAY PULLING FORCE UNTIL IT BECAME FRACTURED. SUBSEQUENT ELECTRON MICROSCOPIC INSPECTION REVEALED THE FRACTURE END HAD BEEN DEFORMED IN A TAPERED SHAPE. THE STATE WAS FOUND TO BE DIFFERENT FROM THAT ON THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE M AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GUIDE WIRE M 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. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE ACTUAL SAMPLE HELD IN A CURVED SHAPE WAS EXPOSED TO TORQUE FORCE BEYOND THE PRODUCT STRENGTH, AND THEN CORE WIRE BROKE OFF AT THAT CURVED SECTION DUE TO METAL FATIGUE. THE URETHANE COATING WAS LIKELY TO HAVE GOT TORN OFF DUE TO HAVING BEEN EXPOSED TO FURTHER EXTERNAL FORCE DURING FURTHER WITHDRAWAL MANIPULATION. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GUIDEWIRE M WAS USED DURING THE PROCEDURE. DURING PTA OF RIGHT SHUNT, AT THE END OF THE TREATMENT A DISSECTION OCCURRED, AND THE GUIDE WIRE WAS USED TO APPROACH IT, HOWEVER, THE MANIPULATION OF IT BECAME DIFFICULT. THE PROCEDURE WAS DISCONTINUED BECAUSE THE GUIDE WIRE SEEMED TO HAVE BEEN FRACTURED UNDER FLUOROSCOPY. THE GUIDE WIRE WAS REMOVED FROM THE PATIENT BY BEING WITHDRAWN TOGETHER WITH A GUIDING CATHETER SLOWLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463494 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 191226

    Patients

    Seq Age Sex Outcome Treatment
    1