BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2223184 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02816
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    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 EXTERNAL EXAMINATION OF THE DEVICE REVEALED THE DEVICE TO BE WITHOUT ISSUE. A FUNCTIONAL EVALUATION WAS PREFORMED 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 BY CUTTING OFF THE OUTER RING AND THEN REMOVING THE THERMOFORMED TUBING AND SILICONE TUBING FROM THE BARBED CONNECTOR. THE BARBED CONNECTOR WAS FOUND TO BE FULLY OCCLUDED ON THE THREADED END OF THE CONNECTOR WITH ADHESIVE. THE ADHESIVE IS PLACED ON THE BARBED CONNECTOR DURING THE MANUFACTURING ASSEMBLY PROCESS. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE GUIDEWIRE SUPPLIED WITH THE KIT WOULD NOT PASS THROUGH THE CONNECTOR. THEREFORE THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. A CAPA IS ONGOING RELATED TO THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR (B)(4) LOT 14004610 AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT.

    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 (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN TRACKING THE PEG TUBE OVER THE GUIDEWIRE RESISTANCE WAS FELT AT THE TRANSITION ZONE AND THE GUIDEWIRE WOULD NOT PASS THROUGH THE TUBE. THE PROCEDURE WAS COMPLETED WITH 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 GOOD.

    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 (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN TRACKING THE PEG TUBE OVER THE GUIDEWIRE RESISTANCE WAS FELT AT THE TRANSITION ZONE AND THE GUIDEWIRE WOULD NOT PASS THROUGH THE TUBE. THE PROCEDURE WAS COMPLETED WITH 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 GOOD.

    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 M00566531 14004610

    Patients

    Seq Age Sex Outcome Treatment
    1