BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ ONE STEP BUTTON¿

    MDR report key: 5014252 · Received August 19, 2015

    Report

    Report Number
    3005099803-2015-02252
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 24, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL EXAMINATION OF THE RETURNED BUTTON, BOLUS FEEDING SET AND DECOMPRESSION TUBE REVEALED NO VISIBLE ISSUES WITH THE COMPONENTS. PRESENCE OF RESIDUE WAS NOTED ON THE COMPONENTS, INDICATING USE/HANDLING. THE BOLUS FEEDING ADAPTOR HAD BEEN INSERTED INTO THE BUTTON UPON RECEIPT AT CIS. A FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING A 60CC SYRINGE FILLED WITH WATER INTO THE PROXIMAL CONNECTOR OF THE BOLUS FEEDING SET AND INJECTING WATER THROUGH THE BUTTON. NO LEAKS OR BLOCKAGE WERE NOTED. A VACUUM WAS THEN PULLED AND THE BUTTON BODY COLLAPSED; THE REFLUX VALVE HELD AS EXPECTED. A SECOND FUNCTIONAL EVALUATION WAS PERFORMED BY PULLING A VACUUM IN THE SYSTEM . THE BUTTON BODY COLLAPSED AND REFLUX VALVE HELD. THE SYRINGE WAS THEN PLACED INTO THE DECOMPRESSION TUBE AND WATER WAS INJECTED; NO BLOCKAGE WAS NOTED. THE DECOMPRESSION TUBE ADAPTOR WAS INSERTED INTO THE BUTTON AND THE REFLUX VALVE OPENED PROPERLY. NO ISSUE WAS NOTED WITH ANY OF THE COMPONENTS. IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE FEEDING TUBE WAS BLOCKED/OCCLUDED, THE REFLEX VALVE DAMAGED AND PRESENCE OF A FOREIGN OBJECT INSIDE THE COMPONENTS. THEREFORE, THE COMPLAINT FAILURE MODE (FEEDING TUBE BLOCKED / OCCLUDED) WAS NOT CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT NUMBER 17619899 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS UNDER 18 YEARS OLD. (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, WHEN WATER WAS INJECTED INTO THE GASTROSTOMY TUBE USING A BOLUS FEEDING ADAPTOR, RESISTANCE WAS MET. IT WAS EXCHANGED WITH GASTRIC DECOMPRESSION TUBE AND THERE WAS DIFFICULTY WHEN TRYING TO LET THE AIR OUT OF THE STOMACH. BOTH DEVICES DIDN'T HAVE ANY ISSUE. THE GASTROSTOMY TUBE WAS REMOVED AND IT WAS NOTICED THAT THERE WAS A BLACK FOREIGN OBJECT, LIKE SEED, INSIDE THE BUTTON DOME. ON (B)(6) 2015, THE GASTROSTOMY TUBE WAS REPLACED WITH A DIFFERENT DEVICE. 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 ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, WHEN WATER WAS INJECTED INTO THE GASTROSTOMY TUBE USING A BOLUS FEEDING ADAPTOR, RESISTANCE WAS MET. IT WAS EXCHANGED WITH GASTRIC DECOMPRESSION TUBE AND THERE WAS DIFFICULTY WHEN TRYING TO LET THE AIR OUT OF THE STOMACH. BOTH DEVICES DIDN'T HAVE ANY ISSUE. THE GASTROSTOMY TUBE WAS REMOVED AND IT WAS NOTICED THAT THERE WAS A BLACK FOREIGN OBJECT, LIKE SEED, INSIDE THE BUTTON DOME. ON (B)(6) 2015, THE GASTROSTOMY TUBE WAS REPLACED WITH A DIFFERENT DEVICE. 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
    547255 ENDOVIVE¿ ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568470 17619899

    Patients

    Seq Age Sex Outcome Treatment
    1