BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2189691 · Received August 3, 2011

    Report

    Report Number
    3005099803-2011-02486
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT AGE OF THE PATIENT IS UNKNOWN HOWEVER, OVER 18 YEARS OLD. 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 DEVICE REVEALED THE SILICONE TUBING TO HAVE BEEN CUT. THE CUT APPEARS TO HAVE BEEN MADE BY SCISSORS OR SIMILAR INSTRUMENT AS INDICATED BY THE STRIATIONS ON THE CUT END. THE DISTAL PORTION OF THE DEVICE INCLUDING THE INTERNAL BOLSTER WAS NOT RETURNED. THE SILICONE TUBING WAS FOUND TO BE CUT LENGTHWISE ADJACENT TO THE OUTER RING. APPROXIMATELY 6CM OF THE THERMOFORMED TUBING WAS STRETCHED, KINKED AND NECKED DOWN TO APPROXIMATELY .112 INCH ADJACENT TO DISTAL END OF CONNECTOR, SPECIFICATION IS .154 ± .003 INCH. THE DISTAL END OF THE THERMOFORMED TUBING PRESENTED SMALL NICKS AND A CUT WAS FOUND AT APPROXIMATELY 4.5CM FROM THE DISTAL END. APPROXIMATELY 9.5CM OF THE PROXIMAL END OF THE THERMOFORMED TUBING WAS STRETCHED, KINKED AND NECKED DOWN TO APPROXIMATELY .060 INCH, MINIMUM OUTER DIAMETER SPECIFICATION AT TIP IS .073 ± .005 INCH. THE PROXIMAL TIP OF THE THERMOFORMED TUBING WAS FOUND TO BE TORN. EVIDENCE WAS FOUND OF SERRATED DEVICE CLAMPED ON THERMOFORMED TUBING AT APPROXIMATELY 8CM FROM PROXIMAL END. THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE BROKE. A VISUAL EXAMINATION OF THE RETURNED SECTION REVEALED THE DEVICE TO HAVE BEEN CUT WITH SCISSORS OR SIMILAR INSTRUMENT. THE STRETCHING AND NECKING DOWN OF BOTH ENDS OF THE THERMOFORMED TUBING INDICATE THE MATERIAL RECEIVED EXCESSIVE TENSILE FORCE. THE CUTS FOUND ON THE DEVICE INDICATE THE USER MOST LIKELY ATTEMPTED TO ENLARGE THE INCISION DURING. ALTHOUGH NO INFORMATION WAS PROVIDED REGARDING THE INCISION 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. BASED ON THE EVENT DESCRIPTION AND THE EVALUATION OF THE RETURNED DEVICE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 14435083 AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14435083.

    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 AS THE PHYSICIAN PUSHED THE PEG KIT THROUGH THE STOMA SITE THE PEG DETACHED AT THE TRANSITION ZONE OUTSIDE THE PATIENT. NOTHING FELL INSIDE THE PATIENT. 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 PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2011 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AS THE PHYSICIAN PUSHED THE PEG KIT THROUGH THE STOMA SITE THE PEG DETACHED AT THE TRANSITION ZONE OUTSIDE THE PATIENT. NOTHING FELL INSIDE THE PATIENT. 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 M00566730 14435083

    Patients

    Seq Age Sex Outcome Treatment
    1