BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 23906939 · Received December 29, 2025

    Report

    Report Number
    9681834-2025-00243
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 29, 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

    D2A: COMMON DEVICE NAME: LAPAROSCOPE, GENERAL & PLASTIC SURGERY. D2B: PRODUCT CODE: GCJ. D4: UDI NO. N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. D10: CONCOMITANT MEDICAL PRODUCTS: MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). G4: 510(K) NUMBER: K923607, K926214. SINCE THE ACTUAL DEVICE WAS NOT RETURNED, THE ANALYSIS OF IT COULD NOT BE PERFORMED. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. HOWEVER, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND THE ANALYSIS OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE 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 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

    TERUMO RECEIVED THE REPORTED INFORMATION. DURING THE IMPLANTATION OF A MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), A RADIFOCUS GLIDEWIRE WAS USED, AND VEIN PERFORATION OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED ON 24DEC2025: THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892422 RADIFOCUS GLIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA RF-GA35153 250530YA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY.