BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 24916391 · Received April 17, 2026

    Report

    Report Number
    1118880-2026-00142
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 17, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    UDI-DI
    00389701012469
    PMA / PMN Number
    K213531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. BASED ON THE EVALUATION OF THE RETURNED SAMPLE THIS REPORT IS NOW DEEMED NOT REPORTABLE. ONE TR BAND AND INFLATOR WERE RETURNED TO TERUMO MEDICAL CORPORATION FOR ASSESSMENT. THE SAMPLE WAS SUBJECTED TO VISUAL ANALYSIS. NO DAMAGE OR DEFORMITIES WERE NOTED ON THE BAND OR INFLATOR. THERE IS 4ML 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. NO AIR BUBBLES WERE OBSERVED FROM THE BALLOON ASSEMBLY OR INFLATION PORT. THE SAMPLE PASSED LEAK TESTING. THE CHECK VALVE WAS DECONSTRUCTED TO CHECK FOR DAMAGE OR FOREIGN MATTER. UPON DECONSTRUCTION, NO DAMAGE OR FOREIGN MATTER WAS FOUND. ONE TR BAND AND INFLATOR WERE RETURNED FOR ASSESSMENT AND THE SAMPLE PASSED LEAK TESTING. THE CHECK VALVE WAS DECONSTRUCTED, AND NO DAMAGE OR FOREIGN MATTER WAS FOUND. THE COMPLAINT CANNOT BE CONFIRMED FOR AIR LEAKAGE ISSUES. THE EXACT ROOT CAUSE CANNOT BE DETERMINED. 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 AND THE DEVICE WAS RELEASED IN A CONFORMING STATE. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THE DEVICE WAS WITHIN MANUFACTURING AND DESIGN SPECIFICATIONS WHEN IT WAS RELEASED FROM TERUMO MEDICAL CORPORATION CONTROL.

    Additional Manufacturer Narrative · 0

    A4: WEIGHT: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: TECH. 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.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE TR BAND WAS APPLIED POST PROCEDURE. 20CC OF AIR WAS ADDED AND THEY REMOVED THE SYRINGE AND THE BALLOON IMMEDIATELY DEFLATED FULLY. THEY WERE ABLE TO PUT UP A BLOOD PRESSURE CUFF AND PUT ON A NEW TR BAND. HEMOSTASIS WAS ACHIEVED. THE SECOND TR BAND USED WAS FROM THE SAME LOT AND IT WAS FINE. THE PATIENT REMAINED IN STABLE CONDITION. THERE WAS NO OBVIOUS HARM TO THE TR BAND. THE DEVICE WAS NOT MANIPULATED AND THE PRODUCT WAS STORED ON A SHELF IN THE ROOM. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS LEFT HEART CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533254 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB24-REG-01 0001260201 00389701012469

    Patients

    Seq Age Sex Outcome Treatment
    1