BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 1922500 · Received December 13, 2010

    Report

    Report Number
    3005099803-2010-05116
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISPOSED OF; 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 ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE, (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE PULLWIRE, FROM THE PATIENT'S STOMA SITE, IT WAS NOTED THE COATING FROM THE PULLWIRE WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH THIS 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568520 13810531

    Patients

    Seq Age Sex Outcome Treatment
    1