BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO RADIFOCUS GUIDE WIRE

    MDR report key: 21605549 · Received March 14, 2025

    Report

    Report Number
    9681834-2025-00041
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 14, 2025
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AT THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510(K): K926214. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. CONFIRMATION OF THE PROVIDED IMAGE FROM THE PROVIDED IMAGE, IT WAS FOUND THAT THE GUIDEWIRE WAS FRACTURED. HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM THE DETAILED CONDITION OF DAMAGE. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND. CAUSE OF OCCURRENCE/CONCLUSION BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE DETAILED CONDITION OF DAMAGE COULD NOT BE CONFIRMED FROM THE PROVIDED IMAGE, AND SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND INVESTIGATION 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 GUIDE WIRE AND/OR ENDOTHERAPY ACCESSORY AND DETERMINE THE CAUSE BY FLUOROSCOPY OR ENDOSCOPE. CONTINUING TO MANIPULATE THE GUIDEWIRE COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDOTHERAPY ACCESSORY." TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 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 THE SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, WHEN THE BALLOON WAS PASSED THROUGH AT A SHARP BEND SECTION, THE FLEXIBLE PART AT THE DISTAL END FRACTURED. THE USE OF THIS PRODUCT WAS DISCONTINUED, AND IT WAS REMOVED. AN ALTERNATIVE PRODUCT WAS USED, AND THE CASE WAS FINISHED. ON (B)(6) CONFIRMED WITH MR. THE DISTAL PART THAT WAS SUSPECTED TO HAVE FRACTURED HAS ALSO BEEN REMOVED. THE PATIENT WAS NOT HARMED (NO REMAINS IN THE BODY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559368 TERUMO RADIFOCUS GUIDE WIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GA18103 241107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention PTA BALLOON CATHETER