BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ ONE STEP BUTTON¿

    MDR report key: 2941920 · Received February 4, 2013

    Report

    Report Number
    3005099803-2013-00573
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 10, 2013
    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

    RECEIVED A ONE STEP BUTTON DELIVERY SYSTEM WITH SNARE POUCH. THE PULL WIRE WAS BENT AND ATTACHED TO THE WIRE LOOP OF THE DILATING TIP. THE BUTTON, HEAT SHRINK, RED STRIP AND BLACK SUTURE WERE STILL ATTACHED TO THE DELIVERY SYSTEM. A PHYSICAL EXAMINATION FOUND THE C-FLEX TUBING WAS FOUND TO HAVE BEEN CUT/ TORN APART AT APPROXIMATELY 21 MM FROM THE DISTAL END. THE C-FLEX TUBING WAS FOUND TO BE STRETCHED AND NECKED DOWN. THE TOTAL LENGTH OF THE C-FLEX TUBING PIECES MEASURED APPROXIMATELY 24 INCHES SPECIFICATION IS 22.75 ± 0.75 INCH. THE SURFACES OF THE TEAR/CUT PRESENTED SERRATIONS CAUSED BY SCALPEL OR SIMILAR INSTRUMENT. ADDITIONALLY THE OUTER SURFACE OF THE DISTAL SECTION OF THE TUBING PRESENTED MARKINGS CAUSED BY HEMOSTATS OR SIMILAR INSTRUMENT. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT FEEDING TUBE DETACHED/ SEPARATED. THE C-FLEX TUBING LENGTH OUT OF SPECIFICATION CONDITION WAS MOST LIKELY CAUSED BY TUBING BEING STRETCHED DURING THE PLACEMENT ATTEMPT. THEREFORE, BASED ON THE EVENT DESCRIPTION AND THE EVALUATION OF OTHER RETURNED DEVICES WITH THE SAME ISSUE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT NUMBER 14954904 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE REPORTED COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 14954904.

    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 ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PEG PLACEMENT PROCEDURE, THE TUBING GOT TORN BETWEEN THE BUTTON AND CATHETER AS IT WAS BEING PULLED THROUGH THE ABDOMINAL WALL. 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) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PEG PLACEMENT PROCEDURE, THE TUBING GOT TORN BETWEEN THE BUTTON AND CATHETER AS IT WAS BEING PULLED THROUGH THE ABDOMINAL WALL. 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
    46650 ENDOVIVE¿ ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568470 14954904

    Patients

    Seq Age Sex Outcome Treatment
    1