BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 24839906 · Received April 10, 2026

    Report

    Report Number
    9681834-2026-00070
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 10, 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

    D2A: CATHETER, CONTINUOUS FLUSH. D2B: KRA. 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: INITIAL REPORTER NAME: UNKNOWN. E1: PHONE NUMBER: UNKNOWN. G4: 510K: K033913. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS AND THE SHIPPING INSPECTION RECORDS. NO OTHER SIMILAR REPORTS WERE FOUND IN THE PAST COMPLAINT FILES. 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 FOLLOWING REPORTED INFORMATION: UPON OPENING THE PACKAGE FOR USE, THE OPERATOR NOTICED THAT THE OUTER LAYER OF THE GUIDEWIRE HAD PEELED OFF. THE EVENT OCCURRED PRE-TREATMENT; THEREFORE, NO PATIENT WAS INVOLVED OR HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537383 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA MC-PE27131 250522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown