BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3071415 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-02589
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF PEG TUBE BREAK. (B)(4) FOR THE REPORTED EVENT OF PEG TUBE BLOCKED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INITIAL G-TUBE - ENTERAL FEEDING ENDOVIVE INITIAL PLACEMENT KIT WAS USED DURING A PEG PLACEMENT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2013 THE PEG TUBE BECAME PARTIALLY OBSTRUCTED WITH A SURGICAL SUTURE CAUSING THE TUBE TO SWELL AND BREAK IN THE MIDDLE. THE PHYSICIAN SHORTENED TUBE BY CUTTING THE PART WHICH HAD TORN AND ATTACHED THE Y PORT. THIS DEVICE REMAINS IMPLANTED IN THE PATIENT. THE PATIENT HOSPITAL STAY WAS PROLONGED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION WAS REPORTED TO BE IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173073 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 67 YR Hospitalization DUODOPA