BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2140912 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02160
    Event Type
    Malfunction
    Date Received
    June 27, 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
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ANALYSIS OF THE USED RETURNED DEVICE SHOWED BLACK RESIDUE ON THE DEVICE. A LAB ANALYSIS REVEALED EVIDENCE OF BOTH FUNGAL SPORES AND DEPOSITION MATERIAL. ELEMENTALLY, THE DEPOSITION MATERIAL APPEARS TO BE BOTH MAGNESIUM AND PHOSPHORUS, WITH A POSSIBLE TRACE OF POTASSIUM. THE MAGNESIUM PHOSPHATE IS A TYPICAL COMPONENT PRESENT IN MEDICINAL PRODUCTS SUCH AS ANTACIDS AND LAXATIVES. THE FUNGAL GROWTH APPEARS TO BE ASPERGILLUM. THE FUNGAL PRESENCE IDENTIFIED IN THE REPORT IS NOT INDICATIVE OF THE CONDITION OF THE STERILE DEVICE SUPPLIED BY BOSTON SCIENTIFIC CORPORATION. IT IS UNKNOWN WHETHER MOLD MAY HAVE BEEN INTRODUCED DURING PATIENT USE OR THROUGH SUBSEQUENT HANDLING POST-REMOVAL. THEREFORE THE MOST PROBABLE CAUSE IS OPERATIONAL CONTEXT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE ACCEPTED DEVICES MET ALL MANUFACTURING SPECIFICATIONS.

    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 (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PHYSICIAN REPORTED, THAT AFTER A SHORT PERIOD, THE PATIENT'S HUSBAND KEEPS SEEING BLACK SPOTS IN THE G-TUBE THAT WILL NOT COME OFF. THE HUSBAND IS WORRIED ABOUT A FUNGAL INFECTION. THE PHYSICIAN REPORTED THERE IS NO FUNGAL INFECTION AND THE BLACK SPOTS DO NOT INTERFERE WITH THE FEEDING. A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD WAS PLACED. 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 STABLE. ON (B)(6), 2011 INVESTIGATION RESULTS SHOWED THERE WAS FUNGUS IN THE TUBE. THIS EVENT IS NOW DEEMED REPORTABLE.

    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 13523997

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR