BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 25028024 · Received April 29, 2026

    Report

    Report Number
    1118880-2026-00162
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 29, 2026
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    UDI-DI
    00389701012476
    PMA / PMN Number
    K213531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: SUPPLY CHAIN OPERATIONS. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE 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 REPORTED INFORMATION: HOURS AFTER PLACEMENT OF THE TR BAND IN POST OP, THE TR BAND BALLOON HAD AN AIR LEAK AND WOULD NOT REMAIN INFLATED. THE TECH THAT INITIALLY PUT THE BAND ON HAD AN ISSUE THAT WAS RESOLVED WITH MORE AIR; HOWEVER, THE BALLOONS WERE ABLE TO BE INFLATED BY THE HCP. SOME BLEEDING OCCURRED. THE DEVICE WAS NOT MANIPULATED BEFORE USE IN ANY WAY. PRODUCT WAS STORED NO DIFFERENTLY FROM ALL OTHER PRODUCTS OF THE SAME KIND. THE DEVICE WAS USED FOR HEMOSTASIS. THE ACCESS WAS A GLIDESHEATH AND THE CLOSURE WAS THE BAND. NO OTHER ITEMS WERE USED. THE PROCEDURE WAS COMPLETED WITH A NEW BAND THAT WAS PLACED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305654 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION TRB29-LRG-01 0001472249 00389701012476

    Patients

    Seq Age Sex Outcome Treatment
    1