BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2182927 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02433
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED A SECTION OF THE DELIVERY SYSTEM APPROXIMATELY 31 CENTIMETERS LONG HAD BEEN CUT FROM THE DEVICE. THE SECTION INCLUDED APPROXIMATELY 27 CENTIMETERS OF SILICONE TUBING, INNER RING, OUTER RING AND THE PULLWIRE ASSEMBLY. THE PULLWIRE LOOP HAD BEEN CUT OFF THE PULLWIRE ASSEMBLY LEAVING A SMALL PORTION OF WIRE REMAINING. THE OUTER DIAMETER OF THE OUTER RING WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE SILICONE TUBING WAS SECURELY ATTACHED TO THE PULLWIRE ASSEMBLY AND TRANSITION BETWEEN THE COMPONENTS WAS FOUND TO BE EVEN AND SMOOTH. THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE WAS DIFFICULT TO PLACE AND THE TRANSITION WAS NOT SMOOTH. ACCORDING TO THE ENDOVIVE SAFETY PEG KIT, DIRECTIONS FOR USE (DFU), GAIN ACCESS SECTION "USING THE EXPOSED BLADE OF THE SAFETY SCALPEL PROVIDED, MAKE A 1 TO 1-1/2 CM INCISION AT THE SELECTED INCISION SITE." AND "NOTE: TOO SMALL AN INCISION MAY CONTRIBUTE TO EXCESSIVE RESISTANCE ON THE PEG TUBE WHEN EXITING THE SKIN." ALTHOUGH THE CUSTOMER STATED THE INCISION WAS OF THE PROPER SIZE, IT IS POSSIBLE THE INCISION WAS TOO SMALL TO PASS THE DEVICE THROUGH THE GASTRIC WALL. ADDITIONALLY USER TECHNIQUE, TORTUOUS ANATOMY AND OTHER PROCEDURAL FACTORS COULD POSSIBLY CONTRIBUTE TO DIFFICULTY PLACING THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 14360033 AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14360033.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS PULLING THE PEG THROUGH THE INCISION THE CONE ON THE END GOT CAUGHT ON THE GASTRIC WALL AND WAS VERY HARD TO COME THROUGH THE WALL OF THE STOMACH. THE PROCEDURE WAS COMPLETED WITH THIS 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS PULLING THE PEG THROUGH THE INCISION THE CONE ON THE END GOT CAUGHT ON THE GASTRIC WALL AND WAS VERY HARD TO COME THROUGH THE WALL OF THE STOMACH. THE PROCEDURE WAS COMPLETED WITH THIS 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 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 M00566720 14360033

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR