BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGREAT

    MDR report key: 25295930 · Received May 26, 2026

    Report

    Report Number
    9681834-2026-00113
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 26, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . E1: TELEPHONE NUMBER: REQUESTED, UNKNOWN. E3: OCCUPATION: RADIOLOGIST. G4: 510K: K033913. SINCE THE ACTUAL DEVICE WAS NOT AVAILABLE, THE FOLLOWING INVESTIGATION WAS PERFORMED. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT NUMBER NO ANOMALY WAS FOUND IN MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS NO RELATED EQUIPMENT PROBLEMS WERE FOUND. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. HISTORY OF TENSILE STRENGTH REGULARLY TESTED NO ANOMALY WAS FOUND IN THE TREND OF THE LOTS AROUND 2.4FR PRODUCTS. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD. IN THIS CASE, IT WAS THOUGHT THAT WHEN PROGREAT WAS INSERTED INTO THE BODY, IT BECAME FRACTURED SINCE A TENSILE LOAD WAS APPLIED TO THE AREA IN THE VICINITY OF THE FRACTURED PART WITH IT TRAPPED BY THE ADHESIVE. HOWEVER, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND THE INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: <WARNING> IF ANY RESISTANCE IS FELT, DO NOT REMOVE THE MICRO CATHETER SYSTEM BY FORCE. WITHDRAW THE CATHETER CAREFULLY TOGETHER WITH THE GUIDING CATHETER. REMOVING THE CATHETER BY FORCE MAY RESULT IN THE CATHETER BREAKAGE/SEPARATION, WHICH MAY NECESSITATE RETRIEVAL. 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 CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT DURING EMBOLIZATION FOR VARICOCELE, AFTER INJECTING THE ADHESIVE (GLUBRAN (GELFOAM) + LIPIODOL) INTO THE BLOOD VESSEL WITH THE CATHETER, THE CATHETER WAS FRACTURED INSIDE INFERIOR VENA CAVA WHEN IT WAS REMOVED. THE DETAILS ARE AS FOLLOWS: RADIOLOGIST, BROKEN, FOLLOWING VISIT TO THE CHU OF TOURS, THE DOCTOR INFORMED THAT SHE ENCOUNTERED AN ISSUE WITH OUR PROGREAT MICROCATHETER DURING A VARICOCELE EMBOLIZATION PROCEDURE THAT TOOK PLACE MONDAY, APRIL 27. DURING THE USE OF GLUE (GLUBRAN + LIPIODOL), AND AFTER WAITING A USUAL AND REASONABLE POLYMERIZATION TIME (A FEW TENS OF SECONDS), WHEN ATTEMPTING TO WITHDRAW THE MICROCATHETER WITH A SHARP PULL, THE MICROCATHETER FRACTURED WITHIN THE INFERIOR VENA CAVA AND IS CURRENTLY REMAINING WITHIN THE BLOOD FLOW WITHOUT ANY CLINICAL CONSEQUENCE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288619 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PP24151ZW 250804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ADHESIVE (GLUBRAN (GELFOAM) + LIPIODOL)