BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1133569 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03649
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED, BUT THE DEVICE EVALUATION IS NOT COMPLETE. THE CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED. THE JULY 2008, 15-MONTH HEMOSTATIC CLIPPING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FOURTH OF FOUR EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORTS 3005099803-2008-003656, 3005099803-2008-03662, AND 3005099803-2008-03648 FOR A DESCRIPTION OF THE FIRST EVENT. A RESOLUTION CLIP DEVICE WAS USED TO TREAT A GI BLEED IN 2008 (FEMALE PT; WEIGHT UNK). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE CLIP GRASPED THE TISSUE, BUT DID NOT DEPLOY. THE PHYSICIAN HAD TO "SHAKE THE CATHETER" TO RELEASE THE CLIP FROM THE CATHETER SUBSEQUENTLY RELEASING THE CLIP FROM THE TISSUE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER RESOLUTION CLIP DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8011406

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR