BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 2130469 · Received June 16, 2011

    Report

    Report Number
    3005099803-2011-01979
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    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

    DEVICE (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF PEG TUBE BROKE. 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

    A VISUAL EXAMINATION OF THE DEVICE FOUND THE BUTTON TO STILL BE INTACT WITH SHEATH, RED STRIP AND BLACK SUTURE TO STILL BE ATTACHED TO THE DELIVERY SYSTEM. THE PULLWIRE DILATING TIP WAS FOUND TO HAVE BEEN PULLED OUT OF THE C-FLEX TUBING. THE PULLWIRE DILATING TIP WAS WITHOUT ISSUE. A VISUAL EXAMINATION AND MEASUREMENTS OF THE C-FLEX TUBING AND PULLWIRE DILATING TIP CONFIRM THAT THE COMPONENTS MET SPECIFICATIONS. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DELIVERY SYSTEM TUBING DETACHED FROM THE BLUE PULLWIRE DILATING TIP. IT CANNOT BE DETERMINED HOW MUCH TENSILE FORCE THE DELIVERY SYSTEM RECEIVED DURING PLACEMENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE OBSERVED DAMAGES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD OF LOT 13717699 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT.

    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), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE PEG TUBE BROKE, ON THE LOOP WIRE END WHEN THEY WERE WITHDRAWING THE DEVICE TO THE OUTSIDE OF THE STOMACH WITH THE PULLWIRE. THE PROCEDURE WAS COMPLETED WITH THIS 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) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE PEG TUBE BROKE, ON THE LOOP WIRE END WHEN THEY WERE WITHDRAWING THE DEVICE TO THE OUTSIDE OF THE STOMACH WITH THE PULLWIRE. THE PROCEDURE WAS COMPLETED WITH THIS 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
    1 ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568520 13717699

    Patients

    Seq Age Sex Outcome Treatment
    1