BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 834435 · Received April 4, 2007

    Report

    Report Number
    6000048-2007-00121
    Event Type
    Injury
    Date Received
    April 4, 2007
    Report Date
    March 8, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GDO
    PMA / PMN Number
    k040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO THE MANUFACTURER; THEREFORE, A FAILURE ANALYSIS CANNOT BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF FAILURE OR THE RELATIONSHIP OF THE FAILURE TO THE REPORTED EVENT. THE CUSTOMER WAS UNABLE TO SUPPLY THE LOT NUMBER; CONSEQUENTLY, THE DEVICE HISTORY RECORD OF THE SUSPECT DEVICE CANNOT BE REVIEWED AND A SEARCH FOR SIMILAR COMPLAINTS CANNOT BE REVIEWED. IN ADDITION, THE FEBRUARY 2007 15-MOTH COMPLAINT TREND REPORT WAS REVIEWED FOR THE HEMOSTATIC CLIPPING DEVICE FAMILY; AN UNFAVORABLE TREND WAS NOTED. NO DATA POINTS EXCEED THE BSC TRIGGER ACTION LIMIT. TWO CONSECUTIVE MONTHS OF INCREASING NUMBER OF COMPLAINTS IS IDENTIFIED AS AN UNFAVORABLE TREND. 55 COMPLAINTS FOR THIS PRODUCT FAMILY WERE REPORTED IN DECEMBER 2006, 61 WERE REPORTED IN JANUARY 2007 AND 74 COMPLAINTS WERE REPORTED IN FEBRUARY 2007. DUE TO THE LOW NUMBER OF INCREASED COMPLAINTS ( A TOTAL INCREASE OF 19 COMPLAINTS), THE LOW MAGNITUDE OF THE NUMBER COMPLAINTS, AND THE LOW CLINICAL SEVERITY OF THE FAILURE MODES, NO SPECIFIC ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    NOTE DATE OF EVENT IS UNK.THE COMPLAINANT HAS REPORTED THAT A PATIENT (AGE AND GENDER UNKNOWN) HAD UNDERGONE A HEMOSTATIC CLIPPING PROCEDURE, IN ORDER TO TREAT A BLEED WITHIN THE STOMACH USING A TOTAL OF TWO BSC RESOLUTION CLIP DEVICES. THIS REPORT IS FOR THE SECOND OF THE TWO DEVICES INVOLVED. (REFER TO MEDWATCH #6000048-2007-00123). IT WAS REPORTED THAT "DURING THE PROCEDURE, ON CLIP DID NOT CLOSE AND THE SECOND CLIP GRASPED THE TISSUE BUT WOULD NOT RELEASE FOR THE CATHETER." IT WAS ALSO REPORTED THAT THE PHYSICIAN REMOVED THE CLIP AND USED ANOTHER CLIP SUCCESSFULLY. HOWEVER, THERE WERE MULTIPLE BLEED SITES SO THE PATIENT WAS THEREFORE, BROUGHT INTO SURGERY. MOREOVER, IT WAS REPORTED THAT THE PATIENT WAS NOT BROUGHT INTO SURGERY DUE TO THE MALFUNCTION OF TWO CLIPS; IT WAS DUE TO THE AMOUNT OF BLEED SITES. NO ADDITIONAL TRAUMA WAS SUSTAINED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE KOD GDO BOSTON SCIENTIFIC M00522611 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention