BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2220994 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02857
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    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. A VISUAL EXAMINATION OF THE DEVICE FOUND BOTH PORTS TO BE IN THE CLOSED POSITION. THE C-CLAMP WAS CLOSED AND LOCATED AT THE 14 CM MARK. THE EXTERNAL BOLSTER WAS WITHOUT ISSUE WAS LOCATED AT THE 2 CM MARK. THE INTERNAL BOLSTER WAS TORN OFF THE TUBING WITH REMNANTS OF THE BOLSTER REMAINING ATTACHED TO THE OUTER DIAMETER OF THE TUBING. THE INNER DIAMETER OF THE INTERNAL BOLSTER WAS TORN AND IRREGULAR AND PRESENTED EVIDENCE OF FAILURE WHILE UNDERGOING TENSILE FORCE. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE INTERNAL BOLSTER DETACHED FROM THE TUBING. THE BOLSTER MOST LIKELY DETACHED WHILE UNDERGOING TENSILE FORCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    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, ON (B)(6), 2011 THE INTERNAL BOLSTER DETACHED AND FELL INSIDE THE PATIENT'S STOMACH. THE INTERNAL BOLSTER WAS RETRIEVED ENDOSCOPICALLY. A DIFFERENT DEVICE WAS PLACED (MANUFACTURER UNKNOWN). 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 M00566521

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other