BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE STANDARD PEG KITS PULL METHOD

    MDR report key: 1170628 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04612
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN IMPLANTED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS REPORTED FOR THIS LOT. THE JULY 2008 15- MONTH INITIAL G-TUBE ENTERAL FEEDING COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON AUG 18, 2008, THAT AN ENDOVIVE STANDARD PEG KITS PULL METHOD DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED IN 2008 (FEMALE PATIENT; WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE Y-CONNECTOR WAS NOTED TO BE BROKEN. THE CONNECTOR HAS NOT BEEN REPLACED. THERE IS NOT INFO AVAILABLE REGARDING THE PROCEDURE OUTCOME. THERE WAS NO INFO AVAILABLE AS A RESULT OF THIS EVENT. THE PT'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 STANDARD PEG KITS PULL METHOD KNT BOSTON SCIENTIFIC CORPORATION M00568201 9083629

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR