BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 10688867 · Received October 16, 2020

    Report

    Report Number
    9681834-2020-00200
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 16, 2020
    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 · 1

    EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI: NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURER DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. PHONE NUMBER: REQUESTED, NOT PROVIDED. PMA/510(K): K122590, K163004. THE ACTUAL SAMPLE (GUIDEWIRE) WAS RETURNED FOR EVALUATION IN THE STATE OF BEING COMBINED WITH NAVICROSS (CATHETER). VISUAL AND MAGNIFYING INSPECTIONS OF THE ACTUAL CATHETER AND THE ACTUAL GUIDEWIRE SAMPLE REVEALED THAT THE URETHANE COATING OF THE GUIDEWIRE HAD BEEN BUCKLED AND CAUGHT IN THE DISTAL END OF THE CATHETER. THE GUIDEWIRE WAS FOUND STUCK IN THE CATHETER. MAGNIFYING INSPECTION OF THE CATHETER CONFIRMED THERE WAS NOT ANY DEFORMITY INCLUDING AN ELONGATION OR CRUSH. X-RAY FLUOROSCOPIC INSPECTION OF THE DISTAL PART OF THE CATHETER CONFIRMED THERE WAS NO BREAKAGE IN THE BRAIDED WIRE OR IN THE COIL MARKER. IT WAS REVEALED THAT THE URETHANE COATING OF THE GUIDEWIRE HAD BEEN FRACTURED AT APPROXIMATELY 15 MM FROM THE DISTAL END OF THE CATHETER. X-RAY CT INSPECTION OF THE FRACTURED URETHANE COATING OF THE GUIDEWIRE REVEALED THAT THE SHAPE OF THE FRACTURE WAS DIAGONAL. X-RAY CT INSPECTION OF THE DISTAL PART OF THE CATHETER REVEALED THAT 0 - 20 MM FROM THE DISTAL END HAD BEEN CLOGGED BY THE BUCKLING PART OF THE URETHANE OUTER LAYER OF THE GUIDEWIRE. X-RAY FLUOROSCOPIC INSPECTION OF THE CATHETER EXCEPT FOR THE DISTAL PART CONFIRMED THERE WAS NO BREAKAGE IN THE BRAIDED WIRE OR IN THE COIL MARKER. THE CATHETER WAS CUT TOGETHER WITH THE GUIDEWIRE AT APPROXIMATELY 2 MM FROM THE DISTAL END, IN ADDITION, THE CATHETER ONLY WAS CUT AT APPROXIMATELY 30 MM FROM THE DISTAL END. THE PART OF THE CATHETER, APPROXIMATELY 2 MM - 30 MM FROM THE DISTAL END, WAS REMOVED TO INSPECT THE STATE OF THE GUIDEWIRE. THE URETHANE COATING HAD BEEN PEELED AND THE CORE WIRE WAS EXPOSED IN THE AREA APPROXIMATELY 4 MM - 15 MM FROM THE DISTAL END OF THE CATHETER, THE URETHANE COATING HAD BEEN EVERTED IN THE DISTAL DIRECTION AND OVERLAPPED IN THE AREA APPROX. 2 MM - 4 MM FROM THE DISTAL END OF THE CATHETER, THE FRACTURE END OF THE URETHANE COATING HAD BEEN ELONGATED. ELECTRON MICROSCOPIC INSPECTION OF THE GUIDEWIRE FOUND SOME ABRASIONS NEAR THE FRACTURE END, AND THE FRACTURE-END SURFACE WAS ROUGH. FROM THIS, IT IS LIKELY THAT SOME KIND OF HARD OBJECT CAME INTO CONTACT WITH THAT AREA. THE INNER DIAMETER OF THE CATHETER AND THE OUTER DIAMETER OF THE UNDAMAGED PART OF THE GUIDEWIRE WERE MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. REPRODUCTIVE TESTING WAS PERFORMED WITH A FACTORY-RETAINED GUIDEWIRE ADVANTAGE SAMPLE WAS COMBINED WITH A METAL NEEDLE, AND THEN MANIPULATED IN THE WITHDRAWAL DIRECTION. AS A RESULT, THE URETHANE COATING OF THE GUIDEWIRE WAS PEELED AND LIFTED. A FACTORY RETAINED NAVICROSS SAMPLE WAS INSERTED OVER THE GUIDEWIRE. AS A RESULT, THE CATHETER WAS CAUGHT IN THE LIFTED PART OF THE URETHANE COATING. SUBSEQUENTLY, AS THE CATHETER WAS ADVANCED UNDER RESISTANCE, THE URETHANE COATING OF THE GUIDEWIRE WAS FRACTURED, PEELED FROM THE FRACTURE, AND THEN EVERTED IN THE DISTAL DIRECTION, AND BUCKLED FINALLY. THE CATHETER WAS CAUGHT IN THE BUCKLED PART OF THE GUIDEWIRE. MAGNIFYING INSPECTION OF THE FRACTURED AREA FOUND THAT THE SHAPE OF THE FRACTURE END AT THE PROXIMAL SIDE WAS DIAGONAL; HOWEVER, THE FRACTURE SURFACE WAS SMOOTH, WHICH WAS NOT SIMILAR TO THAT OBSERVED IN THE GUIDEWIRE. GUIDEWIRE SCRATCHED BY A CALCIFIED LESION: A SCRATCH WAS MADE INTENTIONALLY TO THE URETHANE COATING OF A FACTORY-RETAINED GUIDEWIRE ADVANTAGE SAMPLE. A TENSILE LOAD WAS APPLIED LOCALLY NEAR THE SCRATCHED AREA. AS A RESULT, THE URETHANE COATING GOT ELONGATED AND FRACTURED. MAGNIFYING INSPECTION OF THE PROXIMAL SIDE OF FRACTURE FOUND THAT THE SHAPE OF THE FRACTURE WAS DIAGONAL, AND THE FRACTURE SURFACE WAS ROUGH PARTIALLY, WHICH WAS THE STATE SIMILAR TO THAT OBSERVED IN THE GUIDEWIRE. A FACTORY RETAINED NAVICROSS SAMPLE WAS INSERTED OVER THE GUIDEWIRE SAMPLE. AS A RESULT, THE CATHETER WAS CAUGHT IN A PART OF THE URETHANE COATING LIFTED DUE TO THE FRACTURE. AS THE CATHETER WAS ADVANCED UNDER RESISTANCE, THE URETHANE COATING OF THE GUIDEWIRE WAS PEELED, EVERTED IN THE DISTAL DIRECTION, AND THEN BUCKLED. THE CATHETER WAS STUCK IN THE BUCKLED PART OF THE GUIDEWIRE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD. PN*NA180N3HM/LOT 200211: A REVIEW OF THE DEVICE HISTORY RECORD AND SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: GUIDEWIRE ADVANTAGE: 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. NAVICROSS: CAREFULLY HANDLE THE PRODUCT UNDER FLUOROSCOPY. IF ANY RESISTANCE IS FELT WHILE HANDING THE PRODUCT, IMMEDIATELY STOP THE MANIPULATION AND FIND OUT CAUSE OF THE RESISTANCE IN ORDER TO AVOID DAMAGE TO BLOOD VESSELS AND SEPARATION OR BREAKAGE OF THE PRODUCT. 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 A HARD OBJECT (E.G. CALCIFIED LESION) CAME INTO CONTACT WITH THE URETHANE COATING OF THE ACTUAL GUIDEWIRE SAMPLE AND MADE A SCRATCH IN IT. AFTERWARD, A TENSILE LOAD WAS APPLIED TO THE GUIDEWIRE CAUSING THE URETHANE COATING TO BE ELONGATED AND FRACTURED. THE URETHANE COATING ON THE FRACTURED PART (DISTAL SIDE) BECAME LIFTED; THE ACTUAL CATHETER SAMPLE WAS INSERTED OVER THE GUIDEWIRE AND CAUGHT IN THE LIFTED PART OF THE GUIDEWIRE; WHILE THE CATHETER WAS BEING ADVANCED FURTHER OVER THE GUIDEWIRE UNDER RESISTANCE, THE URETHANE COATING OF THE GUIDEWIRE WAS PEELED FROM THE FRACTURE, EVERTED IN THE DISTAL DIRECTION, AND THEN BUCKLED. THE CATHETER WAS CAUGHT IN THE BUCKLED SECTION OF THE GUIDEWIRE. 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

    THIS REPORT HAS BEEN DEEMED REPORTABLE BASED UPON VISUAL INSPECTION OF THE ACTUAL RADIFOCUS GLIDEWIRE ADVANTAGE DEVICE. THE USER FACILITY REPORTED THE INVOLVED DEVICE WAS USED DURING THE PROCEDURE. IT WAS A BELOW THE KNEE INTERVENTION OF THE LEFT LEG, AN ANTEGRADE APPROACH. USER USED AN 0.018" GLIDEWIRE ADVANTAGE (IS IN THE PACKAGE AS WELL), DURING ADVANCEMENT OF NAVICROSS 0.018" OVER THE WIRE THE ADVANCEMENT BECAME DIFFICULT AND IMPOSSIBLE. THE PHYSICIAN REMOVED CATHETER TOGETHER WITH WIRE AND NOTICED THAT THE M COAT OF THE WIRE WAS DAMAGED. HE GUESSED DUE TO AN OBSTACLE IN THE CATHETER LUMEN. THE PATIENT WAS NOT HARMED. THE PROCEDURE WENT ON WITH A TERUMO STIFF WIRE AND ANOTHER SUPPORT CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156398 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1