BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE? STANDARD PEG KIT

    MDR report key: 3822455 · Received May 20, 2014

    Report

    Report Number
    3005099803-2014-01930
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER 18 YEARS OLD. REPORTED EVENT OF PEG TUBE KINKED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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 STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN HOWEVER REPORTED TO BE DURING THE WEEK OF (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DILATOR TIP OF THE PEG TUBE WAS KINKED WHEN IT WAS PULLED TO THE STOMACH WALL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300327 ENDOVIVE? STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568211 16603509

    Patients

    Seq Age Sex Outcome Treatment
    1