BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE

    MDR report key: 2062855 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01283
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K961345
    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 IS IMPLANTED; 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 PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2011 DURING A CHECK UP THE PHYSICIAN NOTED THAT THE TUBE HAD A CRACK NEAR THE ADAPTOR. A LEAK WAS NOTED; THE PHYSICIAN CUT THE CRACKED PORTION OF THE TUBE AND REATTACHED THE ADAPTOR TO THE TUBE. THIS DEVICE REMAINS IN USE. 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 DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568161 13972803

    Patients

    Seq Age Sex Outcome Treatment
    1