BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 24860824 · Received April 13, 2026

    Report

    Report Number
    1118880-2026-00131
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 13, 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

    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 INFLATOR. THERE IS DRIED BLOOD PRESENT ON THE CHECK VALVE. THERE IS 18ML OF AIR LEFT IN THE BAND. THE SAMPLE WAS SUBJECTED TO FUNCTIONAL TESTING. THE BAND WAS ATTEMPTED TO BE INFLATED AND DEFLATED. UPON FUNCTIONAL TESTING, THE BAND WAS ABLE TO BE INFLATED AND DEFLATED WITH THE RETURNED INFLATOR. ONE TR BAND AND INFLATOR WERE RETURNED FOR ASSESSMENT, AND THE SAMPLE WAS ABLE TO BE INFLATED AND DEFLATED WITH THE RETURNED INFLATOR. THE CHECK VALVE APPEARS TO HAVE DRIED BLOOD ON THE OUTSIDE. THE COMPLAINT CANNOT BE CONFIRMED FOR AIR FLOW ISSUES BECAUSE THE RETURNED SAMPLE WAS ABLE TO BE INFLATED AND DEFLATED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THERE WERE NO ISSUES NOTED DURING THE MANUFACTURE OF THE PRODUCT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. 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

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED . D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED . D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . E3: OCCUPATION: SUPPLY 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 DID NOT DEFLATE WHEN THE RN ATTEMPTED TO REMOVE AIR. THE TR BAND WAS LEFT ON THE PATIENT FOR THE DURATION OF THE CALCULATED REMOVAL TIME THEN THE FULLY INFLATED BAND WAS REMOVED WITH NO COMPLICATIONS. THE PATIENT WAS DISCHARGED AT THE INTENDED TIME. THERE WAS 12ML OF AIR INJECTED AT THE TIME OF APPLICATION. THE PATIENT CONDITION WAS GOOD. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS LEFT CORONARY ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45539 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB24-REG-01 0001374836 00389701012469

    Patients

    Seq Age Sex Outcome Treatment
    1