BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 12777808 · Received November 9, 2021

    Report

    Report Number
    9681834-2021-00190
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 9, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. OCCUPATION- CLINICAL ENGINEER. PMA/510(K)- K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE REVEALED THAT THE OUTER LAYER OF APPROXIMATELY 2MM FROM THE DISTAL END HAD BEEN MISSED, AND THE WIRE HAD BEEN EXPOSED. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE FRACTURED SECTION OF OUTER LAYER HAD BEEN FLAT. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE REVEALED THAT THE FRACTURED SECTION OF OUTER LAYER WAS SHAPED LIKE IT WAS TORN, THE FRACTURED SURFACE OF OUTER LAYER WAS SHAPED LIKE IT GOT CAUGHT FROM TWO DIRECTIONS, AT THE DISTAL END OF WIRE, THERE WAS A MARK OF A FIXED SIZE CUT IN OUR MANUFACTURING PROCESS. THEREFORE, IT WAS INFERRED THAT THERE WAS NO MISSING PIECE OF WIRE. THE OUTER DIAMETER OF THE ACTUAL SAMPLE IN THE VICINITY OF FRACTURED SECTION WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. SIMULATION TEST: BASED ON OUR PAST KNOWLEDGE, SINCE THE OUTER LAYER FRACTURED SECTION OF ACTUAL SAMPLE WAS FLAT SHAPED LIKE IT GOT CAUGHT FROM TWO DIRECTIONS, AND THE PROCEDURE WAS BRAIN TUMOR EMBOLIZATION, IT WAS PRESUMED THAT THE ANGIOGRAPHIC CATHETER USED IN COMBINATION HAD A STOPCOCK. FROM THESE SITUATIONS, WE ASSUMED A SITUATION WHERE THE STOPCOCK WAS OPERATED WITH THE GUIDEWIRE INSERTED AND PERFORMED A SIMULATION TEST. AS A RESULT OF THE SIMULATION TEST, THE FOLLOWING FEATURES WERE CONFIRMED. THE FRACTURED SECTION OF OUTER LAYER WAS SHAPED LIKE IT WAS TORN. THE FRACTURED SURFACE OF OUTER LAYER WAS FLAT SHAPED LIKE IT GOT CAUGHT FROM TWO DIRECTIONS. THESE FEATURES WERE LIKELY TO BE SIMILAR TO THE ACTUAL SAMPLE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. IFU STATES: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. 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 WAS LIKELY THAT WITH THE ACTUAL SAMPLE INSERTED, THE STOPCOCK OF COMBINED CATHETER WAS CLOSED FOR SOME REASON, CAUSING RESISTANCE DURING USE. AFTER THAT, WHEN THE ACTUAL SAMPLE WAS OPERATED IN THE REMOVAL DIRECTION, THE OUTER LAYER APPROX. 2MM FROM THE DISTAL END WAS TORN AND THE PIECE OF IT WAS MISSED. AS FOR THE WIRE, IT WAS INFERRED THAT SINCE THERE WAS A MARK OF A FIXED SIZE CUT IN OUR MANUFACTURING PROCESS AT THE DISTAL END, THERE WAS NO ANOMALY INCLUDING A MISSING PIECE. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE RADIFOCUS GUIDEWIRE M WAS USED TO TREAT A BRAIN TUMOR EMBOLIZATION. WHEN USING THE PRODUCT IN COMBINATION WITH A COMPETITOR'S ANGIOGRAPHIC CATHETER ADVANCING THE PRODUCT INTO THE BLOOD VESSEL, RESISTANCE WAS FELT. WHEN REMOVED FROM THE PATIENT'S BODY, THE OUTER LAYER AT THE DISTAL END WAS PEELED OFF. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED. DEVICES USED: MEDIKIT'S ANGIOGRAPHIC CATHETER 5FR 100CM NO SIDE HOLE, JB2 SHAPE (MODEL NUMBER: ST50BH0.36).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676803 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown JB2 SHAPE: ST50BH0.36| MEDIKIT ANGIOGRAPHIC CATHETER 5FR 100CM