BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE GASTROINTESTINAL SUTURE ANCHOR SET

    MDR report key: 2132363 · Received June 14, 2011

    Report

    Report Number
    1820334-2011-00305
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 13, 2011
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    PMA / PMN Number
    K873606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION AS IT IS STILL IMPLANTED IN THE PATIENT. PER THE EVENT DESCRIPTION THE SUTURE ANCHORS WERE PLACED ON (B)(6) 2009 AND WERE CUT NEARLY FOUR MONTHS LATER ON (B)(6) 2009. THE PRODUCT IFU STATES, "THE SUTURE MAY BE LEFT IN PLACE FOR TWO WEEKS WHILE TRACT FORMATION OCCURS, OR IT MAY BE CUT AFTER GASTROSTOMY PLACEMENT. THIS RELEASES THE ANCHOR INTO THE STOMACH, ALLOWING ITS PASSAGE VIA THE GASTROINTESTINAL SYSTEM." SINCE THE ANCHORS WERE LEFT IN PLACE FOUR MONTHS, RATHER THAN THE SUGGESTED TWO WEEKS, IT IS POSSIBLE THAT THIS LED TO THE (B)(4) PORTION OF THE ANCHOR INCORPORATING INTO THE STOMACH WALL. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. PER QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER MITIGATING ACTIONS ARE NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A MALE PATIENT, (B)(6), UNDERWENT PERCUTANEOUS GASTROSTOMY AND THE PHYSICIAN SELECTED COPE GASTROINTESTINAL SUTURE ANCHOR SET FOR THE PROCEDURE WITH OTHER MANUFACTURER'S 14FR CATHETER. TWO SUTURE ANCHORS WERE PLACED IN THE STOMACH AND THE ENDS OF EACH SUTURES WERE TIED OUTSIDE THE PATIENT'S BODY. ON (B)(6) 2009, THE SUTURE ANCHOR WERE CUT AND THE CATHETER WAS REMOVED. AFTER THIS, THE PATIENT HAD BEEN FOLLOWED BY OTHER DOCTOR AT OTHER HOSPITAL. ON (B)(6) 2011, THE PATIENT VISITED THE ORIGINAL HOSPITAL AND COMPLAINED OF PAIN IN FISTULA AREA. THE FISTULA BECAME A SCAR AS LABIAL FISTULA AND INFLAMMATION WAS CONFIRMED. THEN X-RAY REVEALED THE TWO SUTURE ANCHORS WERE REMAINED IN THE STOMACH. SINCE THEN, THE PATIENT HAS BEEN HOSPITALIZED AND AN ENDOSCOPIC EXAMINATION WILL BE PERFORMED ON (B)(6) 2011, AND THE PHYSICIAN WILL TRY TO REMOVE THE SUTURE ANCHORS. IF THE ENDOSCOPICAL REMOVAL WAS NOT SUCCEEDED, SURGICAL INTERVENTION WILL BE PERFORMED ON (B)(6) 2011. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2011: ON (B)(6) 2011, ENDOSCOPICALLY REMOVAL OF THE SUTURE ANCHORS WERE ATTEMPTED, BUT FAILED DUE TO ADHESION TO THE GASTRIC WALL. ON (B)(6) 2011, THE SUTURE ANCHORS WERE REMOVED SURGICALLY AND THE FISTULA AREA WAS TREATED. THE PATIENT HAD A FAVORABLE OUTCOME AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPE GASTROINTESTINAL SUTURE ANCHOR SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR