BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE STANDARD PEG KITS PUSH METHOD

    MDR report key: 1468590 · Received June 5, 2009

    Report

    Report Number
    3005099803-2009-02723
    Event Type
    Malfunction
    Date Received
    June 5, 2009
    Report Date
    May 8, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: EVENT AND PROCEDURE DATES WERE NOT PROVIDED. IT WAS REPORTED THE BOSTON SCIENTIFIC CORP THAT THE ENDOVIVE INITIAL PLACEMENT PEG KIT PUSH METHOD WAS USED FOR AN ESOPHAGOGASTRODUODENOSCOPY WITH PEG PLACEMENT. PT'S AGE AND WEIGHT WERE NOT PROVIDED. PER THE COMPLAINANT, DURING THE PROCEDURE RESISTANCE WAS ENCOUNTERED, THE PEG TUBE WAS THOUGHT TO BE OCCLUDED IN THE MIDDLE, PREVENTING THE GUIDEWIRE TO PASS THROUGH. THIS PROCEDURE WAS COMPLETED WITH ANOTHER BOSTON SCIENTIFIC CORP PEG KIT, MODEL NUMBER UNK. THERE HAS BEEN NO REPORT OF COMPLICATIONS OR INJURY DUE TO THIS EVENT. POST PROCEDURE THE PT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE STANDARD PEG KITS PUSH METHOD KNT BOSTON SCIENTIFIC CORPORATION M00568251 12414173

    Patients

    Seq Age Sex Outcome Treatment
    1