BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 13058940 · Received December 22, 2021

    Report

    Report Number
    9681834-2021-00241
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 22, 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. PMA/510(K)- K923607,K926214. DEVICE MANUFACTURER DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE WIRE A HAD BEEN EXPOSED AT THE DISTAL END - APPROXIMATELY 3MM FROM THE DISTAL END. SINCE THE LENGTH OF PEELED PIECE WAS APPROXIMATELY 3MM, IT WAS INFERRED THAT THERE WAS NO MISSING PIECE IN THE OUTER LAYER. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE FRACTURED SECTION OF OUTER LAYER ON THE MAIN BODY HAD BEEN TAPERED. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE REVEALED WRINKLES WERE FOUND AT THE FRACTURED SECTION OF OUTER LAYER. THE SIDE SURFACE WAS ENFOLDED IN THE FRACTURED SURFACE OF OUTER LAYER. ELONGATION WAS FOUND ON A PART OF FRACTURED SURFACE OF THE OUTER LAYER. AT THE DISTAL END OF EXPOSED WIRE, A TRACE OF A FIXED SIZE CUT IN OUR PROCESS WAS FOUND. THEREFORE, IT WAS INFERRED THAT THERE WAS NO MISSING PART IN THE WIRE. THE OUTER DIAMETER OF ACTUAL SAMPLE WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. SIMULATION TEST: FROM THE REPORTED ISSUE THAT "WHEN ATTEMPTED TO PASS THE RADIFOCUS THROUGH THE THREE-WAY STOPCOCK ATTACHED TO THE CATHETER, IT WAS CAUGHT AND DID NOT PASS THROUGH. THEREFORE, RADIFOCUS WAS REMOVED.", AS A SIMULATION TEST, THE DISTAL END OF WIRE WAS TRAPPED BY THE STOPCOCK AND OPERATED IN THE REMOVAL DIRECTION. AS A RESULT, PEELING WAS FOUND ON THE OUTER LAYER AT THE DISTAL END, SIMILAR TO THE ACTUAL SAMPLE. VISUAL INSPECTION OF THE SIMULATED PRODUCT FOUND FOLLOWING FEATURES. THE FRACTURED SECTION OF OUTER LAYER WAS TAPERED, AND THE SIDE SURFACE WAS ENFOLDED IN THE FRACTURED SURFACE. ELONGATION WAS FOUND ON A PART OF FRACTURED SURFACE OF THE OUTER LAYER. THESE FEATURES WERE LIKELY TO BE SIMILAR TO THE ACTUAL SAMPLE. 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 WHEN THE ACTUAL SAMPLE AND THE INVOLVED CATHETER WITH A STOPCOCK WERE COMBINED, THE STOPCOCK OPERATION WAS PERFORMED FOR SOME REASON, AND THE DISTAL END OF ACTUAL SAMPLE WAS TRAPPED. THEN, THE OUTER LAYER WAS SEPARATED BY PULLING FORCE WHEN THE ACTUAL SAMPLE WAS REMOVED. NO MISSING PIECE WAS FOUND ON THE OUTER LAYER AND WIRE OF THE ACTUAL SAMPLE. 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 DURING THE PROCEDURE. AT THE TIME OF PREPARATION, WHEN ATTEMPTED TO PASS THE RADIFOCUS THROUGH THE THREE-WAY STOPCOCK ATTACHED TO THE CATHETER, IT WAS CAUGHT AND DID NOT PASS THROUGH. THEREFORE, ONCE RADIFOCUS WAS REMOVED, IT WAS FOUND THAT A FEW MILLIMETERS OF THE DISTAL END OF RADIFOCUS REMAINED IN THE THREE-WAY STOPCOCK, AND THE ENTIRE THREE-WAY STOPCOCK WAS REPLACED. SINCE IT WAS BEFORE RADIFOCUS WAS PLACED INSIDE THE CATHETER, THERE WAS NO PART REMAINED IN THE PATIENT'S BODY. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966486 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA 210705

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown