BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 19861408 · Received July 30, 2024

    Report

    Report Number
    9681834-2024-00132
    Event Type
    Injury
    Date Received
    July 30, 2024
    Report Date
    July 30, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    . G4: 510(K) NUMBER: K923607, K926214. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, ANALYSIS OF IT COULD NOT BE PERFORMED. SINCE THE PRODUCT CODE AND LOT NUMBER WERE UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. REGARDING THE INVOLVED PRODUCT, THERE HAVE BEEN NO REPORTED INCIDENTS ATTRIBUTABLE TO THE MANUFACTURING PROCESS IN THE PAST TWO YEARS. SINCE THE PRODUCT CODE AND LOT NUMBER WERE UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE INVESTIGATED. IN ADDITION, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND THE ANALYSIS OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "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." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 22443441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A TAE FOR A RUPTURE OF HEPATOCELLULAR CARCINOMA, A 0.035-INCH RADIFOCUS GUIDEWIRE WAS INSERTED INTO A SIDE-HOLED GLB. WHEN THE GUIDEWIRE WAS BEING REMOVED, THE TIP BROKE OFF AT THE TIP OF THE SHEATH. EFFORTS WERE MADE TO CAREFULLY RETRIEVE THE DETACHED FRAGMENT USING A 15MM DIAMETER SNARE; HOWEVER, IT MOVED TO THE ORIGIN OF THE RIGHT DEEP FEMORAL ARTERY. ANOTHER ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENT IN THE SAME MANNER; HOWEVER, SINCE IT HAD SHIFTED TO THE PERIPHERY OF THE RIGHT DEEP FEMORAL ARTERY, IT WAS DEEMED UNNECESSARY TO CONTINUE RETRIEVAL. CONSEQUENTLY, THE EMBOLIZATION PROCEDURE PROCEEDED WITHOUT FURTHER RETRIEVAL ATTEMPTS. MINOR INTERVENTION WAS TAKEN TO ADDRESS THE INCIDENT. NO POSSIBLE RESIDUAL DISABILITY WAS ANTICIPATED. THE FRACTURED PIECE REMAINED IN THE PATIENT'S BODY (UNRETRIEVABLE). THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200793 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RFG(UNK) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other| R