BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2032633 · Received March 29, 2011

    Report

    Report Number
    3005099803-2011-00944
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K961345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE WAS PERFORMED AND REVEALED THE MEDICINE PORT AND FEEDING PORTS WERE IN THE OPEN POSITION. THE C-CLAMP WAS CLOSED AND LOCATED AT APPROXIMATELY 2 CENTIMETERS PROXIMAL THE 15 CM MARK. THE EXTERNAL BOLSTER WAS LOCATED AT APPROXIMATELY THE 9 CM MARK AND WAS WITHOUT ISSUE. THE OBTURATOR ANCHOR POCKET IN THE INTERNAL BOLSTER WAS FOUND TO BE TORN LENGTHWISE. THE BOLSTER PRESENTED A SLIGHT GAP ALONG THE MOLD PARTING LINE IN THE TIP OF THE OBTURATOR ANCHOR POCKET WHICH MOST LIKELY CAUSED THE WALL TO BE WEAKENED. THERE ARE NO SPECIFICATIONS REGARDING THE MOLD PARTING LINE OR THE TOP RADIAL WALL THICKNESS AT THE TIP OF THE OBTURATOR ANCHOR POCKET. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE INTERNAL BOLSTER WAS DAMAGED. DURING THE PHYSICAL EVALUATION THE OBTURATOR ANCHOR POCKET WAS FOUND TO HAVE BEEN TORN. THE INTERNAL BOLSTER MOLD PARTING LINE WAS SLIGHTLY WEAK CONTRIBUTING TO THE OBTURATOR ANCHOR POCKET FAILURE WHEN THE POCKET WAS DISTENDED DURING PREPARATION. THEREFORE, BECAUSE IT CANNOT BE DETERMINED HOW MUCH FORCE THE ANCHOR POCKET RECEIVED THE MOST PROBABLE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT 13713403 AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 13713403.

    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.

    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 PROCEDURE WHEN THE PHYSICIAN STRETCHED THE BUMPER FOR INSERTION IT WAS NOTED THAT THE BUMPER WAS CRACKING. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PERCUTANEOUS 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 PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS USED DURING A REPLACEMENT PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN STRETCHED THE BUMPER FOR INSERTION IT WAS NOTED THAT THE BUMPER WAS CRACKING. THE PROCEDURE WAS COMPLETED WITH A NEW SECURI-T PERCUTANEOUS 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 M00568161 13713403

    Patients

    Seq Age Sex Outcome Treatment
    1