BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? SECURI-T?

    MDR report key: 3173612 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-04589
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K961345
    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 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 A SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS USED DURING A REPLACEMENT OF GASTROSTOME PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL, THE BOLSTER DETACHED WHEN REMOVING THE PLACED DEVICE. THE PHYSICIAN RETRIEVED THE DETACHED FRAGMENT WITH FORCEPS ENDOSCOPICALLY. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE . 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273140 ENDOVIVE? SECURI-T? TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other