BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 24817238 · Received April 8, 2026

    Report

    Report Number
    1118880-2026-00083
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 8, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    UDI-DI
    00389701012469
    PMA / PMN Number
    K213531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED, D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, E3: OCCUPATION: SUPPLY TECH. ONE TR BAND AND INFLATOR WERE RETURNED FOR ASSESSMENT. THE SAMPLE WAS SUBJECTED TO VISUAL ANALYSIS. NO DAMAGE OR DEFORMITIES WERE NOTED ON THE BAND OR INFLATOR. THERE IS 0ML OF AIR LEFT IN THE BAND. THE SAMPLE WAS SUBJECTED TO LEAK TESTING. APPROXIMATELY 18ML OF AIR WAS INJECTED INTO THE BAND AND SUBMERGED IN A WATER BATH FOR 30 SECONDS. AIR BUBBLES WERE OBSERVED FROM THE CHECK VALVE. THE SAMPLE FAILED LEAK TESTING. THE CHECK VALVE WAS DECONSTRUCTED TO CHECK FOR DAMAGE OR FOREIGN MATTER. UPON DECONSTRUCTION, A PIECE OF FOREIGN MATTER WAS FOUND. ONE TR BAND AND INFLATOR WERE RETURNED FOR ASSESSMENT AND THE SAMPLE LEAKED AT THE CHECK VALVE DUE TO FOREIGN MATTER. THE COMPLAINT CAN BE CONFIRMED FOR AIR LEAKAGE ISSUES. THE CAUSE IS FOREIGN MATTER IN THE CHECK VALVE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES. A CORRECTIVE ACTION WAS INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: FOLLOWING A CORONARY STENTING, THE TR BAND PLACED THE BAND WITH 12ML. THE PATIENT WAS TAKEN TO RECOVERY, A HEMATOMA WAS DISCOVERED, AND THERE WAS NO AIR IN THE BAND. A NEW BAND WAS PLACED AND THE BLEEDING WAS CONTROLLED. HEMATOMA WAS PRESSED OUT. BLOOD LOSS WAS LESS THAN 250CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879745 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB24-REG-01 0001260201 00389701012469

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male 6FR GLIDE SHEATH SLENDER.