BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVICROSS

    MDR report key: 24607334 · Received March 16, 2026

    Report

    Report Number
    9681834-2026-00051
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 16, 2026
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQY
    PMA / PMN Number
    K173799
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE HAS 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 RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. 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 WIRE AND NAVICROSS WERE STUCK; THEREFORE, THE PHYSICIAN SAW THAT THE TIP OF NAVICROSS WAS BROKEN AFTER HE ATTEMPTED TO PULL IT OUT. THE PROCEDURE OUTCOME WAS NOT REPORTED. AN INTERVENTIONAL (NON-SURGICAL) PROCEDURE WAS REQUIRED TO RETRIEVE THE DEVICE. THE PHYSICIAN USED A BALLOON CATHETER TO REPLACE THE SUPPORT CATHETER. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77703 NAVICROSS CATHETER, PERCUTANEOUS DQY TERUMO CORPORATION, ASHITAKA PN*NA180N3HM 250325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O ABBOTT GUIDE WIRE: HI-TORQUE COMMAND 18.