BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE

    MDR report key: 6838117 · Received September 1, 2017

    Report

    Report Number
    2243441-2017-00127
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Report Date
    September 1, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON, (B)(4) HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION OF EVALUATION CODES. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT FILES. THE USER FACILITY REPORTED SIMILAR EVENTS FROM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION. SEE MDRS 2243441-2017-00125, 2243441-2017-00126, 2243441-2017-00128, 2243441-2017-00129, 2243441-2017-00130, 2243441-2017-00131, 2243441-2017-00132, 2243441-2017-00133, AND 2243441-2017-00134. 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

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE EVALUATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO EVALUATION COULD BE CONDUCTED DUE TO THE DEVICE NOT BEING RETURNED. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE CAUSE OF THE USER'S DIFFICULTIES MAY STEM FROM THE GEARBOX NOT BEING MOVED INTO THE FORWARD LOCK POSITION THUS MISALIGNING THE RACK AND TAMPING TUBE. HOWEVER, WITHOUT THE SAMPLE, IT IS UNCLEAR IF THESE CONDITIONS WERE MET OR IF PATIENT ANATOMY OR USER ERROR CONTRIBUTED TO THE FAILURE. A FURTHER INVESTIGATION HAS BEEN INITIATED. 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

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. WITH NO RETURN OF THE ACTUAL DEVICE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY ARE EXPERIENCING MALFUNCTIONS WITH ANGIO-SEAL EVOLUTION. ADDITIONAL INFORMATION RECEIVED ON 8/7/2017: THE DOCTOR REPORTED 20% ARE DEFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 8, 2017. THEY ARE USUALLY ABLE TO FISH THE TAMPER OUT OF THE DEVICE WITH A HEMOSTAT AND GET IT TO WORK. THEY HAVE HAD AT LEAST 5-10 INSTANCES, BOTH THE 6F AND 8F HAVE FAILED. ONE CLEAR HEMATOMA EPISODE RELATED TO DEVICE FAILURE RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620264 UNK ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1