BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 2063235 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01284
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 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

    THE EXACT AGE OF THE PATIENT IS UNKNOWN HOWEVER, OVER 18 YEARS OLD.DEVICE CODE 1395 RELATES TO 3191 FOR THE REPORTED EVENT OF OUTER SURFACE OF BUTTON WAS ALMOST IN PATIENT'S STOMACH.DEVICE CODE 1104 RELATES TO 3191 FOR THE REPORTED EVENT OF DETACHMENT OF DEVICE COMPONENT.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

    DEVICE EVALUATION: A VISUAL EXAMINATION OF THE DEVICE REVEALED THE BUTTON TO BE OPAQUE AND DISCOLORED. THE BUTTON BODY OUTER DIAMETER, FLANGE LENGTH, AND FLANGE WIDTH WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE DEVICE APPEARED TO BE PROPERLY MOLDED AND WITHOUT ISSUE. A FUNCTIONAL EVALUATION OF THE DEVICE WAS PERFORMED BY INSERTING AND REMOVING THE PLUG FROM THE BUTTON BODY WITHOUT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD OF LOT 13567569 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 13567569. BASED ON THE DEVICE ANALYSIS, THE LABELING REVIEW AND THE ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION. ACCORDING TO THE COMPLAINANT, THE GASTROSTOMA (STOMA SITE) ENLARGED CAUSING THE BUTTON TO NO LONGER FIT PROPERLY, THUS RESULTING IN MIGRATION. THE RESPONSE TO AN FDA REQUEST LETTER FOR ADDITIONAL INFORMATION IS ATTACHED.

    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) 2010.ACCORDING TO THE COMPLAINANT, ON (B)(6) 2011 THE NURSE NOTED THAT A PORTION OF THE OUTER BODY SURFACE OF THE BUTTON WAS ALMOST IN THE PATIENT'S STOMACH. AN ATTEMPT WAS MADE TO STOP THE PORTION OF THE DEVICE FROM GOING IN ANY FURTHER BY USING KOCHER CLAMPS, HOWEVER, THIS PUSHED THE PORTION OF THE DEVICE INTO THE PATIENT'S STOMACH. THE PHYSICIAN TRIED TO REMOVE THE PIECE OF THE DEVICE ENDOSCOPICALLY, HOWEVER, IT WAS DOWN TOWARDS THE LIGAMENT OT TREITZ. THE PHYSICIAN EXPECTED THE PORTION OF THE DEVICE WOULD BE EXCRETED. ON (B)(6) 2011 THE PIECE WAS EXCRETED. A DIFFERENT DEVICE WAS PLACED IN THE PATIENT.THE PATIENT'S CONDITION IS REPORTED TO BE A COMATOSE PERSON, WITH A SMALL, ACTIVE PERISTALSIS, AND A TREND OF EXPANSION OF GASTROSTOMA SLIGHTLY.

    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) 2010. THE PATIENT'S CONDITION IS COMATOSE WITH SLOW BUT ACTIVE PERISTALSIS. IT WAS ALSO REPORTED THAT THE PATIENT'S GASTROSTOMA (STOMA SITE) WAS SLIGHTLY EXPANDED OR ENLARGED. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2011 THE NURSE DISCOVERED THAT THE BUTTON HAD ALMOST MIGRATED INTO THE PATIENT'S STOMACH. AN ATTEMPT WAS MADE TO STOP THE MIGRATION BY USING KOCHER CLAMPS, HOWEVER THIS ATTEMPT PUSHED THE BUTTON FURTHER INTO THE PATIENT'S STOMACH. THE PHYSICIAN TRIED TO REMOVE THE DEVICE ENDOSCOPICALLY HOWEVER, IT WAS NEAR THE LIGAMENT OF TREITZ, AND THEREFORE COULD NOT BE REMOVED. THE PHYSICIAN EXPECTED THE DEVICE WOULD BE EXCRETED BY THE PATIENT. ON (B)(6) 2011 THE DEVICE WAS EXCRETED BY THE PATIENT. A DIFFERENT DEVICE WAS PLACED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568520 13567569

    Patients

    Seq Age Sex Outcome Treatment
    1 Other