BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE¿ ONE STEP BUTTON¿

    MDR report key: 2476186 · Received March 2, 2012

    Report

    Report Number
    3005099803-2012-00603
    Event Type
    Injury
    Date Received
    March 2, 2012
    Date of Event
    January 10, 2012
    Report Date
    February 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PHYSICAL EXAMINATION OF THE BUTTON DEVICE FOUND THE BUTTON BODY SHAFT PRESENTED NICKS AND A DIAGONAL CUT. THE CUT WAS MEASURED TO BE APPROXIMATELY 9 MM LONG. THE CUT SURFACE PRESENTED EVIDENCE OF BEING CAUSED BY A SCALPEL OR SIMILAR INSTRUMENT. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT BUTTON WAS TORN/ SPLIT. ALTHOUGH THE CUSTOMER DID NOT PROVIDE THE SIZE OF THE INITIAL INCISION, IT APPEARS THE INCISION SIZE WAS TOO SMALL FOR PLACEMENT. THE INCISION WAS THEN ENLARGED TO FACILITATE PLACEMENT OF THE DEVICE IN THE PATIENT. IT APPEARS CUTTING OF THE BUTTON BODY SHAFT MOST LIKELY OCCURRED DURING THE ENLARGEMENT OF THE INCISION DURING DEVICE PLACEMENT. THEREFORE, BASED ON THE EVENT DESCRIPTION, ADDITIONAL INFORMATION PROVIDED AND THE EVALUATION OF THE RETURNED DEVICES, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN HOWEVER OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4): CRACK IN FEEDING TUBE. DIFFICULT TO ADVANCE PEG TUBE. 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 PROCEDURE WHILE ATTEMPTING TO PLACE THE BUTTON THE PHYSICIAN MET WITH RESISTANCE. THE PHYSICIAN ENLARGED THE INCISION SITE AND WAS ABLE TO PLACE THIS DEVICE. ON (B)(6), 2012 WHEN WATER WAS INJECTED INTO THE DEVICE A LEAK WAS NOTED. THE PHYSICIAN CHANGED THE DEVICE TO A NEW ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT. UPON REMOVAL OF THE PLACED DEVICE A CRACK WAS FOUND NEAR THE FLANGE. IT IS UNKNOWN IF THE CRACK COULD HAVE OCCURRED WHEN THE INCISION SITE WAS MADE LARGER OR WHEN THE DEVICE WAS INITIALLY PLACED WITH EITHER THE FORCEPS OR SPACER DISK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    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 PROCEDURE WHILE ATTEMPTING TO PLACE THE BUTTON, THE PHYSICIAN MET WITH RESISTANCE. THE PHYSICIAN ENLARGED THE INCISION SITE AND WAS ABLE TO PLACE THIS DEVICE. ON (B)(6) 2012, WHEN WATER WAS INJECTED INTO THE DEVICE, A LEAK WAS NOTED. THE PHYSICIAN CHANGED THE DEVICE TO A NEW ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT. UPON REMOVAL OF THE PLACED DEVICE, A CRACK WAS FOUND NEAR THE FLANGE. IT IS UNKNOWN IF THE CRACK COULD HAVE OCCURRED WHEN THE INCISION SITE WAS MADE LARGER OR WHEN THE DEVICE WAS INITIALLY PLACED WITH EITHER THE FORCEPS OR SPACER DISK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE¿ ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other