BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1062380 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00756
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE WAS DISPOSED AT THE CONCLUSION OF THE PROCEDURE; THEREFORE, A DEVICE EVAL CANNOT BE PERFORMED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTES: THE DATE OF EVENT IS UNK. THIS REPORT IS THE SECOND OF THREE RELATED TO THE EVENT. REFER TO MFR REPORTS #3009055803-2008-00757 AND #3009055803-2008-00758 FOR DETAILS RELATED TO THE OTHER TWO EVENTS. IN 2008, BOSTON SCIENTIFIC CORP BECAME AWARE THAT A RESOLUTION HEMOSTASIS CLIP DEVICE MALFUNCTIONED (PT GENDER, AGE, AND WEIGHT ARE UNK). ACCORDING TO THE COMPLAINANT, THE CLIP "FELL OFF THE CATHETER OUTSIDE THE PT." NO FURTHER DETAILS HAVE BEEN ASCERTAINABLE FROM THE USER FACILITY. IT WAS REPORTED THAT THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML7072405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK