BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2013612 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00678
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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) - INCISION MADE LARGER. (B)(4) - THE REPORTED EVENT OF DIFFICULTY PULLING THE PEG TUBE THROUGH THE INCISION SITE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT IS IMPLANTED; 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 ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NURSE REPORTED THEY HAD EXTREME DIFFICULTY PULLING THE PEG THROUGH THE INCISION SITE. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE CONFIRMED THAT THE INITIAL INCISION SITE WAS OF PROPER LENGTH. THE RESISTANCE WAS FELT AT THE POINT WHERE THE CONE SHAPE ON THE END OF THE PEG MEETS THE SOFT PLASTIC. THE PHYSICIAN EXTENDED THE INCISION SITE AND WAS ABLE TO PLACE THIS DEVICE. 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 M00566461

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other