BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 6976649 · Received October 25, 2017

    Report

    Report Number
    2243441-2017-00163
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. A FURTHER INVESTIGATION IS BEING CONDUCTED FOR THE REPORTED COMPLAINT. 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 FIND FOUR OTHER REPORTS WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THE USER FACILITY REPORTED SIMILAR EVENTS FROM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION. SEE MDRS 2243441-2017-00159, 2243441-2017-00160, 2243441-2017-00161, 2243441-2017-00162, 2243441-2017-00164. 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 AFTER PLACEMENT OF THE ANCHOR, THE PLASTIC TUBE HITCHED IN THE SYSTEM OF THE ANGIOSEAL SO THAT THE COLLAGEN WAS NOT COMPRESSED. THE USER THEN MANUALLY PEELED THE TUBE OUT OF THE HANDPIECE AND ENDED THE PROCESS. THIS HAPPENED WITH A TOTAL OF 6 PRODUCTS OF THE SAME BATCH. FOUR OF THEM WERE USED ON THE PATIENT, THE OTHER TWO USED TO EVALUATE POSSIBLE ERRORS IN THE HANDLING. THE ERROR ALSO OCCURRED IN THESE CASES. EXACT INTERVENTION DATES ARE UNKNOWN. NONE OF THE AFFECTED FOUR PATIENTS SUFFERED ANY DAMAGE. AFTER MANUAL PLACEMENT ALL PATIENTS WERE GIVEN A COMPRESSION BANDAGE FOR A SHORT TIME AND HAD NO COMPLICATIONS. CASE 2 WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757535 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA 5923935

    Patients

    Seq Age Sex Outcome Treatment
    1