BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 1893597 · Received November 9, 2010

    Report

    Report Number
    3005099803-2010-04579
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 18, 2010
    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

    A VISUAL EVALUATION SHOWED THE PULLWIRE WAS ATTACHED ONTO ONE STEP DELIVERY SYSTEM WIRE LOOP. THE C-FLEX TUBING OF THE DELIVERY SYSTEM WAS CUT PROXIMAL THE DILATING TIP. ONLY THE TIP AND WIRE LOOP OF DELIVERY SYSTEM WAS RETURNED. THE DEVICE REVEALED THE BLUE NYLON COATING OF THE PULLWIRE HAD BEEN PEELED AT THE INTERFACE BETWEEN THE PULLWIRE AND DELIVERY SYSTEM WIRE LOOP. THE NYLON COATING OF THE PULLWIRE WAS PEELED DOWN TO WIRE IN MULTIPLE AREAS. THE PEELED NYLON COATING REMAINED ATTACHED TO THE PULLWIRE. NO REMNANTS WERE RETURNED. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE PULLWIRE COATING PEELED. THE EDGE OF THE PERCUTANEOUS STOMA MEASURING DEVICE (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 BACK THROUGH THE PSMD. THE DESIGN OF THE PSMD HAS BEEN DETERMINED TO BE THE MOST PROBABLE ROOT CAUSE OF THE FAILURE. FURTHER INVESTIGATION OF THIS ISSUE IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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.

    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, DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE PULL WIRE, FROM THE PATIENT'S STOMA SITE, IT WAS NOTED THAT THE BLUE COATING HAD PEELED OFF. 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) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE PULL WIRE, FROM THE PATIENT'S STOMA SITE, IT WAS NOTED THAT THE BLUE COATING HAD PEELED OFF. 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 M00568510

    Patients

    Seq Age Sex Outcome Treatment
    1