BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR BAND

    MDR report key: 6810224 · Received August 22, 2017

    Report

    Report Number
    1118880-2017-00058
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 22, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DXC
    UDI-DI
    00389701011349
    PMA / PMN Number
    K152525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1. ONE USED TR REGULAR BAND ASSEMBLY WAS RECEIVED FOR PRODUCT ANALYSIS AT TERUMO MEDICAL CORPORATION. THE TR BAND REGULAR ASSEMBLY WAS RETURNED WITH THE TR BAND INFLATOR. THE RETURNED COMPONENTS WERE DECONTAMINATED. AFTER DECONTAMINATION, THE RETURNED COMPONENTS WERE SUBJECTED TO VISUAL ANALYSIS WHERE NO GROSS ANOMALIES WERE FOUND WITH THE NOZZLE OF THE INFLATOR OR WITH THE CONSTRUCTION OF THE TR BAND REGULAR ASSEMBLY. THERE WAS A NOTABLE STAIN FROM DRIED BLOOD LIKE SUBSTANCE VISIBLE ON THE MAGIC TAPE. WITH NO GROSS ANOMALIES NOTED, THE DEVICE WAS THEN SUBJECTED TO FUNCTIONAL ANALYSIS. THE INFLATOR WAS FILLED WITH 18ML OF AIR, WHICH WAS INJECTED ON TO THE TR BAND REGULAR ASSEMBLY. THE LARGE AND SMALL BALLOON INFLATED APPROPRIATELY. THE TR BAND REGULAR ASSEMBLY WAS THEN SUBMERGED UNDER WATER AND OBSERVED FOR AIR BUBBLE FORMATION. BUBBLE FORMATION WAS OBSERVED WITHIN 5 SECONDS AT THE AIR INJECTION PORT OF THE TR BAND REGULAR ASSEMBLY. UPON THE REALIZATION WHERE THE AIR LEAKAGE WAS OCCURRING, MICROSCOPIC IMAGES OF THE AIR INLET PORT WERE TAKEN TO OBSERVE IF ANY OBSTRUCTIONS EXISTED. NO OBSTRUCTION OR DEFORMATION WAS OBSERVED. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COULD BE CONFIRMED PER THE FUNCTIONAL TESTS THAT WERE PERFORMED. WHILE NO OBSTRUCTION WAS VIEWED IN THE AIR INLET PORT UNDER MICROSCOPY, THE AIR INLET PORT DID NOT PROPERLY SEAL CAUSING THE DEFLATION OF THE BALLOONS. THIS MAY BE DUE TO FOREIGN MATERIAL THAT WAS INTRODUCED WHEN THE INFLATOR WAS INTRODUCED. THIS IS LIKELY NOT A MANUFACTURING ISSUE AS THE DEVICE IS 100% LEAK TESTED AND THERE WAS NO DEFORMATION OF THE VALVE OBSERVED. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY APPLIED THE TR BAND, INFLATED BALLOON, WHEN REMOVED SYRINGE, BALLOON DEFLATED. VALVE NOT WORKING. REMOVED AND APPLIED NEW TR BAND (SAME LOT NUMBER) AND IT WORKED. BLOOD LOSS WAS REPORTED TO BE LESS THAN 250 CC. THE PATIENT WAS STABLE AND UNHARMED. THE PROCEDURE OUTCOME WAS REPORTED TO BE SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590971 TR BAND CLAMP, VASCULAR DXC TERUMO MEDICAL CORPORATION N/A VF01 00389701011349

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR