BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2071767 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01433
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    October 23, 2010
    Report Date
    April 6, 2011
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISPOSED; 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), 2010 (EXACT DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, ON (B)(6), 2010 DURING THE PROCEDURE WHEN THE PHYSICIAN WITHDREW THE PLACED DEVICE THE INTERNAL BOLSTER FELL INTO THE PATIENT'S STOMACH. THE PHYSICIAN ATTEMPTED TO REMOVE THE INTERNAL BOLSTER ENDOSCOPICALLY BUT WAS UNSUCCESSFUL. A FEW DAYS LATER THE PATIENT EXCRETED IT. A NEW SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS PLACED. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.

    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), 2010 (EXACT DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, ON (B)(6), 2010 DURING THE PROCEDURE WHEN THE PHYSICIAN WITHDREW THE PLACED DEVICE THE INTERNAL BOLSTER FELL INTO THE PATIENT'S STOMACH. THE PHYSICIAN ATTEMPTED TO REMOVE THE INTERNAL BOLSTER ENDOSCOPICALLY BUT WAS UNSUCCESSFUL. A FEW DAYS LATER THE PATIENT EXCRETED IT. A NEW SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS PLACED. THE PATIENT'S CONDITION 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 M00568151 13542029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other