BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2231725 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02937
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 15, 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):THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED FEEDING PORT AND THE MEDICATION PORT TO BE CLOSED. THE C-CLAMP WAS LOCATED AT THE 13CM MARK AND WAS CLOSED. THE EXTERNAL BOLSTER WAS LOCATED AT APPROXIMATELY THE 4 CM MARK AND WAS WITHOUT ISSUE. THE INTERNAL BOLSTER WAS FOUND TO BE SEPARATED FROM THE DEVICE. THE DISTAL END OF THE TUBING PRESENTED NO TEARING. A LARGE REMNANT OF THE INTERNAL BOLSTER REMAINED ATTACHED THE OUTER DIAMETER OF THE TUBING. THE INNER DIAMETER OF THE BOLSTER WAS JAGGED AND TORN WITH A LARGE PORTION MISSING. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BOLSTER DETACHED/SEPARATED. THE BOLSTER FAILURE APPEARED TO HAVE OCCURRED WHILE UNDERGOING TENSILE FORCE DURING USE. IT MOST LIKELY DETACHED DUE TO EXCESSIVE FORCE BEING USED DURING REMOVAL OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 14017052 WHICH REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14017052.

    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, DURING THE REPLACEMENT PROCEDURE, ON (B)(6), 2011, WHEN THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE PATIENT TO BE REPLACED IT WAS NOTED THE INTERNAL BOLSTER WAS MISSING. THE BOLSTER WAS INSIDE THE PATIENT'S STOMACH AND REMOVED ENDOSCOPICALLY. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE 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) 2011. ACCORDING TO THE COMPLAINANT, DURING THE REPLACEMENT PROCEDURE, ON (B)(6) 2011, WHEN THE PHYSICIAN WAS REMOVING THE DEVICE FROM THE PATIENT TO BE REPLACED IT WAS NOTED THE INTERNAL BOLSTER WAS MISSING. THE BOLSTER WAS INSIDE THE PATIENT'S STOMACH AND REMOVED ENDOSCOPICALLY. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE. 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 M00568151 14017052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other