BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1000467 · Received February 21, 2008

    Report

    Report Number
    3005099803-2008-00185
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE JANUARY 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

    A RESOLUTION CLIP DEVICE WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON A FEMALE PT (WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, THE CLIP HAD "CLOSED ON THE BLOOD VESSEL; [HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE CLIP FROM THE DEVICE], THE CLIP WOULD NOT RELEASE. THE PHYSICIAN GENTLY MOVED THE SHEATH WHICH CAUSED THE VESSEL TO BLEED." FOLLOW-UP INFO PROVIDED BY THE COMPLAINANT STATED THAT "THE VESSEL BLEED WAS A RESULT OF THE TRAUMA SUSTAINED UPON REMOVAL OF THE CLIP." REPORTEDLY, THE BLEEDING WAS CONTROLLED WITH THE "USE OF INJECTION AND A BSC GOLD PROBE HEMOSTASIS DEVICE. THE DEPLOYMENT ISSUE RESULTED IN A REPORTED PROCEDURE DELAY OF 20-30 MINUTES." AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE KOD BOSTON SCIENTIFIC CORPORATION M00522600 OML6102602

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR