BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1771718 · Received July 28, 2010

    Report

    Report Number
    3005099803-2010-03238
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE BUTTON DOME SHOWED IT HAD BEEN CORRECTLY MANUFACTURED AND SECURELY ATTACHED TO THE BODY OF THE DEVICE. BUTTON VALVE WAS PROPERLY ATTACHED AND NO DAMAGE WAS FOUND. FUNCTION OF VALVE WAS VERIFIED BY PLACING 20CC SYRINGE IN BODY OF BUTTON AND DRAWING A VACUUM TO ENSURE THE VALVE SEALED PROPERLY TO BODY. THE BODY SHAFT COLLAPSED DURING VACUUM CONFIRMING THAT NO LEAKAGE OCCURRED AROUND THE VALVE. THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE VALVE LEAKED. THE FUNCTION OF THE VALVE WAS VERIFIED BY DRAWING A VACUUM USING A SYRINGE. IF THE VALVE HAD NOT FUNCTIONED PROPERLY, A LEAK WOULD HAVE OCCURRED AND NO VACUUM COULD HAVE BEEN PULLED ON THE BODY. BECAUSE THE VALVE FUNCTIONED AS DESIGNED IT WAS NOTED BY THE COMPLAINT INVESTIGATION SITE (CIS) THAT THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. THEREFORE, ROOT CAUSE COULD NOT BE CONFIRMED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING A REPLACEMENT PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, REFLUX OF GASTRIC CONTENTS OCCURRED SHORTLY AFTER PEG REPLACEMENT. THE PHYSICIAN ADVANCED AN OBTURATOR DOWN TO ACTIVATE THE REFLUX VALVE BECAUSE HE/SHE FELT THE PROBLEM WAS WITH THE VALVE HOWEVER, THIS DID NOT RESOLVE THE ISSUE. A FEEDING TUBE WAS CONNECTED TO THE BUTTON TO PREVENT REFLUX. A NEW BUTTON REPLACEMENT GASTROSTOMY DEVICE WILL BE PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED DURING A REPLACEMENT PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, REFLUX OF GASTRIC CONTENTS OCCURRED SHORTLY AFTER PEG REPLACEMENT. THE PHYSICIAN ADVANCED AN OBTURATOR DOWN TO ACTIVATE THE REFLUX VALVE BECAUSE HE/SHE FELT THE PROBLEM WAS WITH THE VALVE HOWEVER, THIS DID NOT RESOLVE THE ISSUE. A FEEDING TUBE WAS CONNECTED TO THE BUTTON TO PREVENT REFLUX. A NEW BUTTON REPLACEMENT GASTROSTOMY DEVICE WILL BE PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTON REPLACEMENT GASTROSTOMY DEVICE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568300

    Patients

    Seq Age Sex Outcome Treatment
    1