BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE SAFETY PEG KITS PULL METHOD

    MDR report key: 2153402 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-01975
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Report Date
    February 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE; THEREFORE, THE DEVICE MANUFACTURE DATE CANNOT BE DETERMINED. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED NO INDICATION OF USE. FUNCTIONAL EVAL FOUND THAT THE DEVICE SAFETY SHIELD WAS LOCKED AND COULD NOT BE OPENED. COMPLAINT CONFIRMED. THE CAUSE OF THE MALFUNCTION IS UNDETEREMINED. A REVIEW OF THE CUSTOMER'S SHIPMENT HISTORY IDENTIFIED THE LAST THREE LOTS (11057900, 11057902, AND 11013111) SHIPPED PRIOR TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD OF EACH LOT REVEALED NO ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE REVEALED ADD'L COMPLAINTS FOR ONE OF THESE LOTS; TWO COMPLAINTS FOR AN UNRELATED ISSUE (LEAKAGE) WERE REPORTED FOR LOT 11057900. (B)(4).

    Description of Event or Problem · 1

    NOTE: DATE OF EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON (B)(6) 2008, THAT A SAFETY PEG PULL DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PROTECTIVE SHIELD ON SCALPEL COULD NOT BE MOVED TO EXPOSE THE BLADE. THE PROCEDURE WAS COMPLETED WITH THE SCALPEL FROM A SECOND COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE SAFETY PEG KITS PULL METHOD KNT BOSTON SCIENTIFIC CORPORATION M00566521 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK