BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? STANDARD PEG KIT

    MDR report key: 3162767 · Received June 11, 2013

    Report

    Report Number
    3005099803-2013-04938
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. 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 ENDOVIVE PEG KIT PULL METHOD 20FR WAS USED IN A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE INTERNAL BOLSTER OF THE PEG WAS EMBEDDED IN THE ABDOMINAL WALL. THE PHYSICIAN REPOSITIONED THE EXTERNAL BOLSTER TO INCREASE THE LENGTH OF THE TUBE AT THE INTRA-ABDOMINAL SEGMENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT BUT WERE UNSUCCESSFUL. IF FURTHER INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENT MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262403 ENDOVIVE? STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention