BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP BUTTON(TM)

    MDR report key: 1934289 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05186
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE REVEALED THE C-FLEX TUBING TO BE TORN IN TWO AT THE PROXIMAL END OF SHRINK WRAP. THE C-FLEX TUBING WAS STRETCHED INDICATING EXTREME TENSILE FORCE. THE DELIVERY SYSTEM CONNECTOR WAS ALSO BROKEN IN TWO AND APPROXIMATELY 2 CENTIMETERS OF THE PROXIMAL END OF CONNECTOR REMAINED INSIDE C-FLEX TUBING. THE FRACTURED ENDS OF BOTH THE C-FLEX TUBING AND THE CONNECTOR APPEAR TO HAVE FAILED WHILE RECEIVING TORSIONAL FORCES. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE BROKE IN TWO. PHYSICAL EXAMINATION REVEALED THE DEVICE RECEIVED BOTH TENSILE AND TORSIONAL FORCES CAUSING THE FAILURE. IT MOST LIKELY DETACHED DUE TO EXCESSIVE FORCE BEING USED DURING REMOVAL OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS 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 13210230.

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN HOWEVER, OVER 18 YEARS OLD. (B)(4) - RETRIEVAL OF DEVICE. (B)(4) THE REPORTED EVENT OF PEG TUBE BROKE. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO AGE REPORTED FROM: EXACT AGE OF THE PATIENT IS UNKNOWN HOWEVER OVER 18 YEARS OLD TO: EXACT AGE OF PATIENT IS UNKNOWN HOWEVER OVER 70 YEARS OLD.

    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 (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN WAS PULLING PEG THROUGH THE STOMA SITE, THE TUBE SNAPPED AWAY FROM THE BUTTON INSIDE THE PATIENT. THE TUBE WAS RETRIEVED HOWEVER; THE DEVICE THAT WAS USED IS UNKNOWN. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT NOT BEING AVAILABLE. THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN WAS PULLING PEG THROUGH THE STOMA SITE THE TUBE SNAPPED AWAY FROM THE BUTTON INSIDE THE PATIENT. THE TUBE WAS RETRIEVED HOWEVER; THE DEVICE THAT WAS USED IS UNKNOWN. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT NOT BEING AVAILABLE. THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHEN THE PHYSICIAN WAS PULLING PEG THROUGH THE STOMA SITE THE TUBE SNAPPED AWAY FROM THE BUTTON INSIDE THE PATIENT. THE TUBE WAS RETRIEVED HOWEVER; THE DEVICE THAT WAS USED IS UNKNOWN. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT NOT BEING AVAILABLE. THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON(TM) TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00563030 13210230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other