BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1962121 · Received January 17, 2011

    Report

    Report Number
    3005099803-2011-00066
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Report Date
    December 27, 2010
    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

    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 BUTTON WAS PERFORMED AND NO ISSUES WERE FOUND WITH DEVICE. THE BUTTON BODY, INNER DIAMETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE FLANGE PLUG OUTER DIAMETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. A FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING THE FLANGE PLUG INTO THE BUTTON BODY WITHOUT ISSUE. A SECOND FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING A SYRINGE INTO THE BUTTON BODY AND PULLING A VACUUM. THE BUTTON HELD THE VACUUM, VALVE SEALED PROPERLY AGAINST THE BUTTON BODY. A THIRD FUNCTIONAL EVALUATION WAS PERFORMED BY INJECTING WATER THROUGH THE DEVICE USING A SYRINGE, NO LEAKS WERE NOTED. A VACUUM WAS THEN PULLED WHILE WATER REMAINED IN THE BUTTON BODY AND THE VALVE HELD A VACUUM AS EXPECTED. THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BUTTON LEAKED. THE DEVICE MEASUREMENTS AND FUNCTIONAL EVALUATIONS CONFIRM THAT THE DEVICE MET SPECIFICATIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 13695634.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING A REPLACEMENT PROCEDURE PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, POST PROCEDURE (EXACT DATE IS UNKNOWN), GASTROINTESTINAL TRACT FLUID WAS LEAKING FROM THE FLANGE OF THE BUTTON. THE PROCEDURE WAS COMPLETED WITH A NEW BUTTON REPLACEMENT GASTROSTOMY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING A REPLACEMENT PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE (EXACT DATE IS UNKNOWN), GASTROINTESTINAL TRACT FLUID WAS LEAKING FROM THE FLANGE OF THE BUTTON. THE PROCEDURE WAS COMPLETED WITH A NEW BUTTON REPLACEMENT GASTROSTOMY 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 BUTTON REPLACEMENT GASTROSTOMY DEVICE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568290 13695634

    Patients

    Seq Age Sex Outcome Treatment
    1