BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE® SAFETY PEG KIT

    MDR report key: 3223443 · Received July 12, 2013

    Report

    Report Number
    3005099803-2013-06587
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT: (B)(6). (B)(4) FOR THE REPORTED EVENT OF FEEDING TUBE OCCLUDED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2013, THE NURSE FELT RESISTANCE WHEN FLUSHING THE TUBE. IT APPEARED THAT THE PEG TUBE WAS OCCLUDED. A GASTROGRAFIN STUDY WAS PERFORMED AND IT WAS FOUND THAT THERE WAS LEAKING AND EXTRAVASATION. THE PEG TUBE GOT FRACTURED OR PULLED OUT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE GASTRIC TUBE, THE BOLSTER DETACHED INSIDE THE INTRAPERITONEAL CAVITY OF THE PATIENT. THE PATIENT'S FAMILY REQUESTED NOT TO REMOVE THE DETACHED BOLSTER. IT WAS PLANNED TO PLACE A NEW PEG TUBE IN 2-4 WEEKS AFTER INTRA-ABDOMINAL INFLAMMATORY PROCESS SUBSIDED. THE PATIENT WAS REPORTED TO BE DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 UNDER HOSPICE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322948 ENDOVIVE® SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566461 15967424

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR