BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 1911548 · Received December 1, 2010

    Report

    Report Number
    3005099803-2010-04933
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT'S AGE IS NOT KNOWN HOWEVER, OVER 18 YEARS OLD. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT HAS BEEN IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6), 2010 THERE WAS DIFFICULTY WHEN TRYING TO INJECT THE ENTERAL NUTRITION INTO THE BUTTON. AN ENDOSCOPE WAS USED TO CONFIRM PROPER PLACEMENT OF THE BUTTON IN THE STOMA. THREE ADAPTERS WERE USED TO TRY AND INJECT THE NUTRITIONAL SUPPLEMENT, STRAIGHT, RIGHT AND DECOMPRESSION. ON (B)(6), 2010 A BOSTON SCIENTIFIC SALES REPRESENTATIVE WENT TO THE HOSPITAL AND EXPLAINED ABOUT THE BACKFLOW VALVE. THE PHYSICIAN GATED THE BACKFLOW VALVE USING THE DECOMPRESSION TUBE AND A COTTON SWAB. AFTER SEVERAL TRIES THE PHYSICIAN WAS ABLE TO GET THE NUTRITION INJECTED. DURING THE TIME THERE WAS DIFFICULTY INJECTING THE NUTRITIONAL SUPPLEMENT, THE PATIENT WAS GETTING FED VIA DRIP INFUSION AND A NASOGASTRIC TUBE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568470 13752292

    Patients

    Seq Age Sex Outcome Treatment
    1