BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 1961418 · Received January 14, 2011

    Report

    Report Number
    3005099803-2011-00051
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 24, 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 COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED THE C-CLAMP AND BOTH THE PORTS ON THE Y-PORT WERE IN THE CLOSED POSITION. BLUE TAPE WAS FOUND ON THE TUBING OF THE RIGHT ANGLE CONNECTOR. THE OUTER DIAMETER OF THE RIGHT ANGLE CONNECTOR WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE INNER DIAMETER OF THE BUTTON BODY WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. A FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED BY INSERTING THE RIGHT ANGLE CONNECTOR INTO THE BUTTON BODY. WATER WAS THEN INJECTED THROUGH THE FEEDING PORT OF THE RIGHT ANGLE CONNECTOR AND INTO THE BUTTON USING A SYRINGE. NO LEAKS WERE NOTED. A SECOND FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED BY PULLING ON THE SYRINGE WHILE WATER REMAINED IN THE BUTTON BODY AND RIGHT ANGLE WAS CONNECTED TO THE TUBE AND AGAIN NO LEAKS WERE NOTED, THE VALVE HELD THE VACUUM AS EXPECTED. THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE LEAKED AT CONNECTION BETWEEN THE BUTTON AND THE RIGHT ANGLE CONNECTOR. THE COMPONENTS WERE WITHIN SPECIFICATION AND NO ISSUES WERE NOTED DURING THE FUNCTIONAL EVALUATIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    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 IN (B)(6), 2010 (EXACT DATE IS UNKNOWN).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.ACCORDING TO THE COMPLAINANT, THE PATIENT HAS BEEN IN THE HOSPITAL SINCE THE PLACEMENT OF THE BUTTON. POST PROCEDURE (EXACT DATE IS UNKNOWN), THE HOSPITAL NOTED ENTERAL NUTRIENT IS LEAKING FROM THE CONNECTOR OF THE ONE STEP BUTTON, AND THE CAP IS LOOSE AND OPENS ON ITS OWN. IN ADDITION, THE RIGHT ANGLE ADAPTER DOES NOT HAVE A TIGHT FIT INTO THE CONNECTOR OF THE ONE STEP BUTTON. THE PATIENT IS SCHEDULED TO GET A NEW ONE STEP BUTTON IN (B)(6), 2011 (EXACT DATE IS UNKNOWN)..

    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 IN (B)(6), 2010 (EXACT DATE IS UNKNOWN). 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. ACCORDING TO THE COMPLAINANT, THE PATIENT HAS BEEN IN THE HOSPITAL SINCE THE PLACEMENT OF THE BUTTON. POST PROCEDURE (EXACT DATE IS UNKNOWN), THE HOSPITAL NOTED ENTERAL NUTRIENT IS LEAKING FROM THE CONNECTOR OF THE ONE STEP BUTTON, AND THE CAP IS LOOSE AND OPENS ON ITS OWN. IN ADDITION, THE RIGHT ANGLE ADAPTER DOES NOT HAVE A TIGHT FIT INTO THE CONNECTOR OF THE ONE STEP BUTTON. THE PATIENT IS SCHEDULED TO GET A NEW ONE STEP BUTTON IN (B)(6), 2011 (EXACT DATE IS UNKNOWN). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568520

    Patients

    Seq Age Sex Outcome Treatment
    1