BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE? STANDARD PEG KIT

    MDR report key: 3243067 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-07485
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF TROCAR BENT (B)(4) FOR THE REPORTED EVENT OF SNARE WIRE DIFFICULTY RETRACTING 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 ENDOVIVE INITIAL PLACEMENT KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TROCAR WAS BENT WHEN IT ENTERED THE STOMACH WALL. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD DIFFICULTY RETRACTING THE SNARE LOOP MAKING IT DIFFICULT TO MANEUVER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE IN GOOD HEALTH CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343118 ENDOVIVE? STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568390 15799806

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR