BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? SECURI-T?

    MDR report key: 4232946 · Received November 6, 2014

    Report

    Report Number
    3005099803-2014-03492
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 10, 2014
    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

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER 18 YEARS OLD. 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 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. REPORTEDLY, THE PHYSICIAN REPLACES THE DEVICE FOR THE PATIENT EVERY TWO OR THREE MONTHS. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL OF THE GASTROSTOMY TUBE, SEVERE RESISTANCE WAS MET. AFTER SEVERAL ATTEMPTS MADE BY THE PHYSICIAN, TWISTING THE TUBE AND PULLING THE TUBE IN DIFFERENT DIRECTIONS, THE ISSUE WAS NOT RESOLVED. THE PHYSICIAN EXPANDED THE OPENING OF THE GASTROSTOMA TO PULL THE GASTROSTOMY TUBE HOWEVER, THE INTERNAL BOLSTER DETACHED INSIDE THE PATIENT¿S STOMACH. THE DETACHED BOLSTER WAS RETRIEVED ENDOSCOPICALLY. 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
    715705 ENDOVIVE? SECURI-T? TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other