BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE STANDARD PEG KITS PUSH METHOD

    MDR report key: 2492688 · Received January 6, 2009

    Report

    Report Number
    3005099803-2009-00041
    Event Type
    Malfunction
    Date Received
    January 6, 2009
    Date of Event
    December 8, 2008
    Report Date
    December 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE CODES WERE SELECTED BY THE MANUFACTURER BASED ON INFORMATION OBTAINED FROM THE USER FACILITY. BOSTON SCIENTIFIC ASSIGNED ID #: 1828132-1230-08-005-R. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO SECOND OF TWO DEVICES THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORT NUMBER 3005099803-2009-00042 FOR A DESCRIPTION OF THE OTHER EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2008 THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE (PATIENT GENDER, AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE "THEY COULD NOT GET THE GUIDE WIRE THROUGH THE PEG TUBE, THERE WAS NO HOLE FOR IT TO GO THROUGH". THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE STANDARD PEG KITS PUSH METHOD. 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 STANDARD PEG KITS PUSH METHOD KNT BOSTON SCIENTIFIC CORPORATION M00568211 12050348

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK