BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

    MDR report key: 2140547 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02113
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXTERNAL EXAMINATION OF THE PEG PUSH DEVICE REVEALED THE DEVICE TO BE WITHOUT ISSUE. A FUNCTIONAL EVALUATION WAS PERFORMED BY ATTEMPTING TO PASS A GUIDEWIRE THROUGH THE DELIVERY SYSTEM. THE GUIDEWIRE WOULD NOT PASS THROUGH THE BARBED CONNECTOR FROM EITHER DIRECTION. THE DEVICE WAS DISASSEMBLED. THE BARBED CONNECTOR WAS PIN GAUGED AND IT WAS FOUND TO BE PARTIALLY OCCLUDED BY A CLEAR SUBSTANCE THAT FORMED A RING AROUND THE INNER WALL OF THE CANNULA. A PORTION OF THE ADHESIVE WAS FOUND TO SCRAPE FROM THE CANNULA ID DURING THE PIN GAUGING PROCESS. THE ADHESIVE IS PLACED ON THE BARBED CONNECTOR DURING THE MANUFACTURING ASSEMBLY PROCESS, THEREFORE THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 14327843 AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14327843.

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN HOWEVER IN THEIR LATE (B)(6). 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 AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE TRACKING THE PUSH PEG OVER THE GUIDEWIRE THE GUIDEWIRE BECAME LODGED AT THE JUNCTION BETWEEN THE HARD AND SOFT PLASTIC TUBING. THE PROCEDURE WAS COMPLETED WITH THE SAME GUIDEWIRE AND A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE TRACKING THE PUSH PEG OVER THE GUIDEWIRE THE GUIDEWIRE BECAME LODGED AT THE JUNCTION BETWEEN THE HARD AND SOFT PLASTIC TUBING. THE PROCEDURE WAS COMPLETED WITH THE SAME GUIDEWIRE AND A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566470 14327843

    Patients

    Seq Age Sex Outcome Treatment
    1