BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEM

    MDR report key: 1910194 · Received November 30, 2010

    Report

    Report Number
    3005099803-2010-04844
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K014297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.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 A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING A REPLACEMENT PROCEDURE (EXACT UPN AND PROCEDURE DATE ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN PUT THE OBTURATOR DOWN THROUGH THE MIDDLE OF THE BUTTON SHAFT. THE ROD MIGHT HAVE DISRUPTED THE ANTI-REFLUX VALVE. THE PATIENT STATES "MY LIQUID NUTRITION MOVES MORE SLOWLY THAN USUAL AND SOMETIMES THERE IS REFLUX AFTER FEEDING." IT WAS SUGGESTED BY THE BSC REPRESENTATIVE THAT THE PATIENT GO BACK TO HIS PHYSICIAN FOR GUIDANCE WITH THIS DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK367

    Patients

    Seq Age Sex Outcome Treatment
    1