BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1964332 · Received January 19, 2011

    Report

    Report Number
    3005099803-2011-00070
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Report Date
    December 28, 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

    A VISUAL EXAMINATION REVEALED THE BUTTON TO BE ENCRUSTED WITH HARD RESIDUE. THE BUTTON BODY, INNER DIAMETER WAS PIN GAUGED AND FOUND TO BE OUT OF 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 WAS WITHIN SPECIFICATIONS. A FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING THE FLANGE PLUG INTO THE BUTTON BODY WITH DIFFICULTY DUE TO THE HEAVY RESIDUE. REMOVAL OF THE FLANGE PLUG WAS ALSO DIFFICULT DUE TO THE RESIDUE. A SECOND FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING THE BOLUS ADAPTOR INTO THE BUTTON BODY, INSERTION AND REMOVAL WAS DIFFICULT DUE TO THE HEAVY RESIDUE. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE PLUG/ CAP DID NOT HAVE A TIGHT FIT IN THE BUTTON BODY. THE HARD RESIDUE BUILD-UP INSIDE THE PROXIMAL END OF THE BUTTON BODY PREVENTED PROPER INSERTION OF THE PLUG AND ALSO PREVENTED THE PLUG FROM FORMING A TIGHT SEAL INSIDE THE BUTTON BODY. THEREFORE THE MOST PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT IS SELECTED FOR THE COMPLAINT.

    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 NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH 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 REPLACEMENT PROCEDURE (DATE UNKNOWN).ACCORDING TO THE COMPLAINANT, POST PROCEDURE (DATE UNKNOWN) THE CAP ON THE BUTTON WAS LOOSE. IT DID NOT HAVE A TIGHT FIT TO THE BUTTON BODY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. A NEW BUTTON REPLACEMENT GASTROSTOMY DEVICE WILL BE PLACED IN (B)(6), 2011 DURING A ROUTINE REPLACEMENT.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 (DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, POST PROCEDURE (DATE UNKNOWN) THE CAP ON THE BUTTON WAS LOOSE. IT DID NOT HAVE A TIGHT FIT TO THE BUTTON BODY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. A NEW BUTTON REPLACEMENT GASTROSTOMY DEVICE WILL BE PLACED IN (B)(6), 2011 DURING A ROUTINE REPLACEMENT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1