BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP BUTTON

    MDR report key: 970542 · Received December 28, 2007

    Report

    Report Number
    6000048-2007-00352
    Event Type
    Injury
    Date Received
    December 28, 2007
    Date of Event
    November 12, 2007
    Report Date
    November 30, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS UNDETERMINED. THE OCTOBER 2007 15-MONTH ONE STEP BUTTON - ENTERAL FEEDING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A ONE STEP BUTTON WAS REMOVED DURING AN ENTERAL FEEDING DEVICE EXCHANGE PROCEDURE ON A FEMALE PATIENT (WEIGHT UNKNOWN) IN 2007. ACCORDING TO THE COMPLAINANT, "WHEN TH[E] OSB [ONE STEP BUTTON] WAS PULL[ED] TO THE ABDOMEN WALL FOR [AN] EXCHANGE, 2CM OF THE GASTRIC WALL [WHICH] WAS PUNCTURED GOT TORN. THEREFORE, THE DOME WAS PLACED BETWEEN THE GASTRIC WALL AND [THE] ABDOMEN WALL. NO ABNORMAL BLEEDING [WAS] NOTED. THE PATIENT WENT INTO SURGERY IMMEDIATELY [FOR REMOVAL OF] THE BUTTON. THE GASTRIC WALL WAS SEW[N] UP [AND] AFTER SEVERAL DAYS, THE PATIENT [RECEIVED] A NASOGASTRIC TUBE FOR FEEDING." THE PHYSICIAN STATED THAT "THE GASTRIC WALL WAS WEAKENED BY AGING [AND] THE ROUGHNESS OF [THE] PLASTIC TUBE CAUSED THIS INCIDENT." FOLLOWING THE PROCEDURE, "NO PATIENT COMPLICATIONS [WERE] NOTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON KGC BOSTON SCIENTIFIC CORPORATION M00568510 11075842

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention