BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 24990312 · Received April 24, 2026

    Report

    Report Number
    1118880-2026-00180
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 24, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    UDI-DI
    00389701012469
    PMA / PMN Number
    K152525
    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

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . E3: OCCUPATION: REGISTERED CARDIOVASCULAR INVASIVE SPECIALIST (RCIS). THE ACTUAL DEVICE HAS NOT 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 ACCORDING TO BEST PRACTICES. PATENT HEMOSTASIS WITH APPROXIMATELY 15ML OF AIR WHILE ON THE CATH LAB PROCEDURE TABLE. THE TECH THEN TURNED AROUND TO CLEAN OFF THE BACK TABLE AND THROW AWAY DRAPES, BOWL, ETC WHICH TOOK APPROXIMATELY TWO MINUTES; THEN LOOKED BACK AT THE PATIENT'S WRIST AND IT WAS BLEEDING, THE BALLOONS RELEASED THE AIR ALL ON THEIR OWN. THE TECH THEN PULLED AN ADDITIONAL TR BAND TO REPLACE THE TR BAND THAT HAD LEAKED AS A RESULT OF UNINTENDED TITRATION OF AIR. THE PROCEDURE WAS COMPLETED BY USING THE SECOND TR BAND. THE PATIENT WAS STABLE AND THERE WAS NO HEMATOMA OBSERVED. THE TYPE OF PROCEDURE PERFORMED WAS PERCUTANEOUS CORONARY INTERVENTION (PCI) TO RIGHT COMMON FEMORAL ARTERY (RCA). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THEY ARE NOT AWARE OF THE DEVICE BEING MANIPULATED BEFORE USE IN ANY WAY - PRE-USE OR DURING STORAGE. THE PRODUCT WAS STORED PRIOR TO USE IN A BIN IN THE PROCEDURE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513809 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB24-REG 0001333735 00389701012469

    Patients

    Seq Age Sex Outcome Treatment
    1