BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 24221649 · Received January 30, 2026

    Report

    Report Number
    9681834-2026-00008
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    December 31, 2025
    Report Date
    January 30, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    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: CONTACT: REQUESTED, UNKNOWN. E1: TELEPHONE: REQUESTED, UNKNOWN. G4: 510K: K033913. THE ACTUAL DEVICE WAS NOT AVAILABLE FOR RETURN; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. APPEARANCE CONFIRMATION WITH PROVIDED IMAGE FOR INVESTIGATION REQUEST THE OUTER LAYER HAD BEEN FRACTURED AND THE REINFORCING COIL HAD BEEN ELONGATED IN ACTUAL CATHETER. 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. BASED ON THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING 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 FOR SOME REASON. HOWEVER, SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND ANALYSIS OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF THE OCCURRENCE. RELEVANT IFU REFERENCE: 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 MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE MICROCATHETER DID NOT ADVANCE SMOOTHLY DURING THE PROCEDURE. AFTER WITHDRAWAL, IT WAS DISCOVERED THAT THE TIP OF THE MICROCATHETER HAD FRACTURED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED BY REPLACING IT WITH A PRODUCT OF THE SAME MODEL. THERE WAS NOT ANY RESIDUALS LEFT IN THE PATIENT. PATIENT IS WELL. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78357 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PE27131 240607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown