BEUDAMED
    FDA Adverse Event Other Summary report: N

    GT, MINI-ONE

    MDR report key: 2338382 · Received October 26, 2011

    Report

    Report Number
    1526012-2011-00001
    Event Type
    Other
    Date Received
    October 26, 2011
    Date of Event
    September 4, 2011
    Report Date
    September 26, 2011
    Product Code
    KNT
    PMA / PMN Number
    K945618
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE INFORMATION, INCLUDING FOLLOW-UP WITH THE INITIAL REPORTER, THE INCIDENT IS NOT A REPORTABLE EVENT PER 21 CFR, SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. IN ADDITION, BASED ON A REVIEW OF THE INFORMATION, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PT'S CONDITION. INSTEAD, IT IS BELIEVED THAT THE INITIAL PLACEMENT DEVICE CAUSED THE LESIONS AND ULCER, RESULTING IN THE EMESIS. APPLIED MEDICAL TECHNOLOGY (AMT) WAS NOT THE MANUFACTURER OF THE INITIAL PLACEMENT DEVICE. THE INITIAL REPORTER STATES THAT AMT'S REPLACEMENT DEVICE WAS IN USE FOR ONLY 2 DAYS, TOO SHORT A PERIOD OF TIME TO CAUSE THE LESIONS AND ULCER. MOREOVER, IF THE BALLOON OF THE AMT DEVICE WERE PROPERLY FILLED, THE INFLATED BALLOON WOULD PROTECT FROM A PROTRUDING CATHETER TIP. THE INITIAL REPORTER PROVIDED NO ETIOLOGY OF THE LESIONS OR EMESIS. NOR WAS THE AMT DEVICE RETURNED TO AMT FOR ANALYSIS. IT SHOULD ALSO BE NOTED THAT THE AMT REPLACEMENT DEVICE IS A DISPOSABLE DEVICE, REQUIRING PERIODIC REPLACEMENT. ALTHOUGH, IT IS NOT BELIEVED THE AMT DEVICE FAILED OR MALFUNCTIONED WITHIN THE 2 DAY PERIOD NOTED BY THE INITIAL REPORTER, ALL DEVICES OF THIS TYPE, WHETHER MANUFACTURED BY AMT OR A COMPETITOR, WILL EVENTUALLY FAIL AND REQUIRE REPLACEMENT. FINALLY, THE INITIAL REPORTER WRITES IN THE MEDWATCH REPORT THAT THE PT HAS A HISTORY OF GASTROINTESTINAL BLEEDING.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESCRIPTION: THE PT HAD A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE CHANGED TO A MINI-ONE GASTROSTOMY TUBE (GT) CHANGE OUT LAST MONTH WITHOUT INCIDENT. LATER, PT HAD AN EPISODE OF COFFEE-GROUND EMESIS AND CAME TO THE PEDIATRIC EMERGENCY ROOM. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) DIAGNOSTIC IMAGING EXAM REVEALED FIVE DISTINCT LESIONS WHICH WERE THE SAME SIZE AND SHAPE AS THE TIP OF THE NEW MINI-ONE GT. ONE LESION WAS ULCERATED AND THE CAUSE OF THE GASTROINTESTINAL (GI) BLEED. THE MINI-ONE GT WAS REMOVED AND REPLACED WITH A DIFFERENT MANUFACTURER'S 14 FRENCH GT. THE PT HAD NO FURTHER BLEEDING EPISODES. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? GASTROSTOMY FEEDING TUBE CHANGEOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GT, MINI-ONE GASTROSTOMY TUBE KNT GT, MINI-ONE 11052481

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Other