BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE¿ STANDARD PEG KIT

    MDR report key: 4860021 · Received June 22, 2015

    Report

    Report Number
    3005099803-2015-01585
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    April 2, 2014
    Report Date
    May 28, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    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. 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.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD PERISTOMAL FASCIITIS. THE DUODOPA THERAPY WAS TEMPORARILY DISCONTINUED. REPORTEDLY, THE PERISTOMAL FASCIITIS WAS NOT RELATED TO THE DUODOPA THERAPY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD PERISTOMAL FASCIITIS. THE DUODOPA THERAPY WAS TEMPORARILY DISCONTINUED. REPORTEDLY, THE PERISTOMAL FASCIITIS WAS NOT RELATED TO THE DUODOPA THERAPY. 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. ADDITIONAL INFORMATION RECEIVED ON MARCH 14, 2016: A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY REPLACEMENT PROCEDURE WAS PERFORMED WITH NO PATIENT COMPLICATIONS AND THE ISSUE WAS RECTIFIED. THE PATIENT'S CONDITION AFTER THE PROBLEM WAS RESOLVED WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD PERISTOMAL FASCIITIS. THE DUODOPA THERAPY WAS TEMPORARILY DISCONTINUED. REPORTEDLY, THE PERISTOMAL FASCIITIS WAS NOT RELATED TO THE DUODOPA THERAPY. 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. ADDITIONAL INFORMATION RECEIVED ON MARCH 14, 2016: A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY REPLACEMENT PROCEDURE WAS PERFORMED WITH NO PATIENT COMPLICATIONS AND THE ISSUE WAS RECTIFIED. THE PATIENT'S CONDITION AFTER THE PROBLEM WAS RESOLVED WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404345 ENDOVIVE¿ STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568381

    Patients

    Seq Age Sex Outcome Treatment
    1 Other