BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2221027 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02819
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE REPORTED EVENT OF DIFFICULTY PULLING PEG TUBE THROUGH STOMA SITE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISPOSED; 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-02818 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE WIRE ON THE END OF THE PEG TUBE BROKE AS THE PHYSICIAN WAS PULLING THE DEVICE THROUGH THE STOMA SIGHT. THE PHYSICIAN ENLARGED THE STOMA SITE AND GOT A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD HOWEVER THE SECOND PEG TUBE WAS NOT ABLE TO COME THROUGH THE INCISION SITE. THE PROCEDURE WAS ABORTED. THE PHYSICIAN STATED THE INCISION WAS OF PROPER SIZE INITIALLY AND THE NURSE STATED THAT THE PATIENT MAY HAVE HAD MESH SURGICALLY IMPLANTED. THE SECOND PROCEDURE WAS ABORTED DUE TO THE PATIENT'S ANATOMY. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566460 14259468

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR