BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 25290602 · Received May 26, 2026

    Report

    Report Number
    1118880-2026-00276
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 26, 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. A2: DATE OF BIRTH: 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 WAS PLACED AND TITRATED TO 12ML OF AIR. THE TECH NOTICED BALLOON WAS LOSING AIR AND PINCHED THE AIR TUBE WITH A KELLY CLAMP THAT STOPPED THE LEAK. A NEW TR BAND WAS PLACED, AND THE PUNCTURE SITE WAS CONTROLLED. THE PATIENT HAD NO ADVERSE OUTCOMES, COMPLICATIONS, BLEEDING, OR HEMATOMA. THE PATIENT WAS IN GOOD CONDITION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE PERFORMED PRIOR TO THE USE OF THE TR BAND WAS LEFT CORONARY ANGIOGRAM. THE DEVICE DID NOT HAVE NOTICEABLE DAMAGE. THE TR BAND STARTED TO DEFLATE IMMEDIATELY. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY - PRE-USE OR DURING STORAGE. THE PRODUCT IS STORED PRIOR TO USE IN THE ORIGINAL PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249399 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB24-REG-01 0001432064 00389701012469

    Patients

    Seq Age Sex Outcome Treatment
    1