BEUDAMED
    FDA Adverse Event Summary report: N

    CAPIO SLIM

    MDR report key: 7299675 · Received February 26, 2018

    Report

    Report Number
    MW5075544
    Date Received
    February 26, 2018
    Date of Event
    February 21, 2018
    Report Date
    February 23, 2018
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FHQ
    Report Source
    Voluntary report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    SURGERY WAS BEING PERFORMED THAT REQUIRED A CAPIO SLIM SUTURE CAPTURING DEVICE. THE THREAD OF THE SUTURE FOR THE CAPIO KEPT BREAKING WHEN USED ON THE PT, 3 SEPARATE CAPIO DEVICES WERE OPENED. EACH OF THEM NOT WORKING PROPERLY. WE HAD OPENED 4 SUTURE/BULLET PACKETS AND EACH THREAD WERE BREAKING UPON USE. PT WAS NOT HARMED. THIS HAS NOT BEEN THE FIRST TIME THIS ISSUE HAS OCCURRED. REF NUMBER FOR THE SUTURING DEVICE IS 831826, LOT #21522919. SUTURE/BULLET PACKET REF #833136, LOT #74E1700355.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141691 CAPIO SLIM CAPIO SLIM FHQ BOSTON SCIENTIFIC 831826 21522919
    141692 CAPIO SLIM CAPIO SLIM FHQ BOSTON SCIENTIFIC 831826 21522919
    141693 CAPIO SLIM CAPIO SLIM FHQ BOSTON SCIENTIFIC 831826 21522919
    141694 SUTURE SUTURE GAT BOSTON SCIENTIFIC 833136 74E1700355
    141695 SUTURE SUTURE GAT BOSTON SCIENTIFIC 833136 74E1700355
    141696 SUTURE SUTURE GAT BOSTON SCIENTIFIC 833136 74E1700355
    141697 SUTURE SUTURE GAT BOSTON SCIENTIFIC 833136 74E1700355

    Patients

    Seq Age Sex Outcome Treatment
    1