BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 1980166 · Received February 7, 2011

    Report

    Report Number
    3005099803-2011-00179
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    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 VISUAL EVALUATION SHOWED ONE STEP BUTTON DELIVERY SYSTEM WITH PERCUTANEOUS STOMA MEASURING DEVICE (PSMD) AND PULLWIRE. THE PULLWIRE WAS THREADED THROUGH PSMD AND ATTACHED ONTO ONE STEP DELIVERY SYSTEM WIRE LOOP. THE BUTTON, SHEATH, RED STRIP AND SUTURE WERE STILL INTACT ON THE DELIVERY SYSTEM. A VISUAL EXAMINATION OF THE DEVICE REVEALED THE BLUE NYLON COATING OF THE PULLWIRE HAD BEEN PEELED AT THE INTERFACE BETWEEN THE PULLWIRE AND DELIVERY SYSTEM WIRE LOOP. A LARGE REMNANT OF COATING WAS WRAPPED AROUND THE WIRE LOOP. AN ADDITIONAL LOOSE REMNANT OF THE COATING WAS SENT BACK. THE NYLON COATING OF THE PULLWIRE WAS PEELED DOWN TO WIRE IN MULTIPLE AREAS. PULLWIRE WAS FOUND TO BE KINKED IN MULTIPLE PLACES. THE PSMD PRESENTED NO ISSUES AND FLOWERETTES FUNCTIONED AS INTENDED. THE PSMD STYLET WAS NOT RETURNED. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE PULLWIRE COATING PEELED. THE EDGE OF THE PSMD HAS BEEN DETERMINED TO BE TOO SHARP THUS CATCHING ON THE NYLON COATING OF THE PULLWIRE AND CAUSING THE COATING TO PEEL AS THE PULLWIRE IS PULLED THROUGH THE PSMD. THE DESIGN OF THE PSMD HAS BEEN DETERMINED TO BE THE MOST PROBABLE ROOT CAUSE OF THE FAILURE. A CAPA IS ONGOING RELATED TO THIS ISSUE. THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE INTERNAL BUMPER HAD BEEN PULLED THROUGH THE STOMA SITE. NO ISSUE WAS FOUND WITH THE DELIVERY SYSTEM OR THE BUTTON. ADDITIONALLY, IT WAS NOTED THAT THE PULL WIRE PRESENTED MULTIPLE KINKS. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE OBSERVED DAMAGES IS CONSIDERED OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 13573701.

    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 INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS REMOVING THE PULLWIRE FROM THE PATIENT'S STOMACH, THE COATING ON THE PULLWIRE PEELED OFF. IN ADDITION, THE INTERNAL BUMPER WAS PULLED THROUGH THE STOMA SITE. THE PHYSICIAN REPORTED THAT THE INCISION SITE WAS OF THE PROPER SIZE AND NO COATING FROM THE PULL WIRE FELL INTO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED TO BE CRP (C-REACTIVE PROTEIN) LEVEL INCREASE AND MILD PERITONITIS. CURRENTLY, A DECOMPRESSION ADAPTOR IS BEING USED. IT IS UNKNOWN WHETHER ANY MEDICATION WAS PRESCRIBED TO TREAT THE PERITONITIS. THE CONDITION IS REPORTED TO BE STABLE. THE PHYSICIAN IS MONITORING THE PATIENT'S CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ONE STEP INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS REMOVING THE PULLWIRE FROM THE PATIENT'S STOMACH THE COATING ON THE PULLWIRE PEELED OFF. IN ADDITION THE INTERNAL BUMPER WAS PULLED THROUGH THE STOMA SITE. THE PHYSICIAN REPORTED THAT THE INCISION SITE WAS OF THE PROPER SIZE AND NO COATING FROM THE PULL WIRE FELL INTO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED TO BE CRP(C-REACTIVE PROTEIN) LEVEL INCREASE AND MILD PERITONITIS. CURRENTLY A DECOMPRESSION ADAPTOR IS BEING USED. IT IS UNKNOWN WHETHER ANY MEDICATION WAS PRESCRIBED TO TREAT THE PERITONITIS. THE CONDITION IS REPORTED TO BE STABLE. THE PHYSICIAN IS MONITORING THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568520 13573701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other