BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 1182296 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04943
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTES: THIS REPORT PERTAINS TO THE SECOND OF TWO REPORTED MALFUNCTIONS OCCURING DURING THE SAME PROCEDURE. REFER TO MFR REPORT #3005099803-2008-04942 FOR DETAILS REGARDING THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A SECOND ATTEMPT TO DEPLOY A RESOLUTION CLIP DEVICE, IT WAS DIFFICULT TO RELEASE THE CLIP. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8040713

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK