BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3111213 · Received May 14, 2013

    Report

    Report Number
    3005099803-2013-03878
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 12, 2012
    Report Date
    April 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF FEEDING TUBE KINKED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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 ON (B)(4) 2013 THAT AN ENDOVIVE INITIAL PLACEMENT KIT WAS USED IN PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (DATE IS UNKNOWN.) ACCORDING TO THE COMPLAINANT, ON (B)(6) 2012, THE PATIENT FELL CAUSING THE PEG TUBE TO KINK. THE PEG TUBE WAS REMOVED AND THE PATIENT WAS GIVEN ANTIPARKINSONIAN MEDICATIONS ORALLY. ATTEMPTS WERE MADE TO OBTAIN INFORMATION ON THE PATIENT'S CONDITION BUT THESE WERE UNSUCCESSFUL. IF NEW RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212583 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK518

    Patients

    Seq Age Sex Outcome Treatment
    1 DUODOPA