BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1994056 · Received February 16, 2011

    Report

    Report Number
    3005099803-2011-00338
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THE BUTTON TO BE ENCRUSTED WITH RESIDUE. THE BUTTON BODY WAS PIN GAUGED AND FOUND TO BE WITHIN SPECIFICATIONS. INSERTION OF PIN GAUGE WAS DIFFICULT DUE TO THE HEAVY, HARD RESIDUE IN PROXIMAL END OF THE BODY. THE FLANGE PLUG OUTER DIAMETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE OUTER DIAMETER OF THE BUTTON BODY WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. A FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING THE FLANGE PLUG INTO THE BUTTON BODY WITH SLIGHT DIFFICULTY DUE TO THE HEAVY RESIDUE. A SECOND FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING A SYRINGE INTO THE BUTTON BODY AND DRAWING A VACUUM. THE BUTTON BODY COLLAPSED AND VALVE HELD. A THIRD FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING A SYRINGE INTO THE BUTTON BODY AND INJECTING WATER INTO THE BUTTON. NO LEAKS WERE NOTED. A VACUUM WAS THEN PULLED WHILE THE BODY WAS FILLED WITH WATER AND NO LEAKS WERE NOTED AND THE BUTTON BODY COLLAPSED AND VALVE HELD. A FOURTH FUNCTIONAL EVALUATION WAS PERFORMED BY CUTTING THE BUTTON BODY IN HALF, CLOSING THE BUTTON PLUG INTO THE BODY, INSERTING A SYRINGE INTO THE BUTTON BODY AND INJECTING WATER AGAINST THE PLUG. NO LEAKS WERE NOTED AND PLUG HELD WHILE UNDERGOING PRESSURE FROM THE SYRINGE. THE COMPLAINT OF CONTENTS LEAKING FROM THE GASTROSTOMA AND LOOSE PLUG/CAP COULD NOT BE CONFIRMED. THE BUTTON COMPONENTS WERE WITHIN SPECIFICATION AND NO ISSUES WERE NOTED DURING THE FUNCTIONAL EVALUATIONS OF THE VALVE AND PLUG. THERE ARE ADDITIONAL KNOWN PHYSIOLOGICAL EFFECTS OF THE PROCEDURE THAT COULD BE RELATED TO THE LEAK AT THE STOMA SITE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, THE DEVICE WAS REPLACED ON (B)(6), 2011 WITH A NEW BUTTON REPLACEMENT GASTROSTOMY DEVICE BECAUSE THE CAP ON THE DEVICE WOULD OPEN ON ITS OWN. IN ADDITION STOMACH CONTENT LEAKED FROM AROUND THE STOMA SITE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS REPLACED ON (B)(6), 2011 WITH A NEW BUTTON REPLACEMENT GASTROSTOMY DEVICE BECAUSE THE CAP ON THE DEVICE WOULD OPEN ON ITS OWN. IN ADDITION STOMACH CONTENT LEAKED FROM AROUND THE STOMA SITE. 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 BUTTON REPLACEMENT GASTROSTOMY DEVICE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568340

    Patients

    Seq Age Sex Outcome Treatment
    1