BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2182851 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02478
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 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

    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

    RESIDUE WAS PRESENT ON THE DEVICE TO INDICATE USE. A VISUAL EXAMINATION OF THE DEVICE WAS PERFORMED AND REVEALED THE MEDICINE PORT AND FEEDING PORT WERE IN THE CLOSED POSITION, THE C-CLAMP WAS OPEN. THE EXTERNAL BOLSTER WAS LOCATED AT APPROXIMATELY THE 15 CM MARK AND WAS WITHOUT ISSUE. THE OBTURATOR ANCHOR POCKET OF THE INTERNAL BOLSTER WAS FOUND TO HAVE BEEN TORN STARTING AT THE TIP THROUGH THE TOP OF THE ANCHOR POCKET. THE TEAR WAS JAGGED IN APPEARANCE. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE INTERNAL BOLSTER WAS TORN. DUE TO RESIDUE ON THE DEVICE UPON PRODUCT RETURN AND THE CONDITION OF THE INTERNAL BOLSTER INDICATE THAT THE OBTURATOR ANCHOR POCKET WAS MOST LIKELY TORN DURING PREPARATION PRIOR TO INSERTION INTO THE PATIENT. THEREFORE THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. BASED UPON THE INVESTIGATION RESULTS THE EVENT HAS BEEN CHANGED TO NON-REPORTABLE. REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 14215387 AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14215387.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SECURI-T PECUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS USED DURING A REPLACEMENT PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE UNPACKING IT WAS NOTED THAT THE INTERNAL BUMPER HAD A TEAR. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PECUTANEOUS REPLACEMENT GASTROSTOMY TUBE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SECURI-T PECUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS USED DURING A REPLACEMENT PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, WHILE UNPACKING IT WAS NOTED THAT THE INTERNAL BUMPER HAD A TEAR. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PECUTANEOUS REPLACEMENT GASTROSTOMY TUBE. 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 M00568151 14215387

    Patients

    Seq Age Sex Outcome Treatment
    1