BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 1964329 · Received January 19, 2011

    Report

    Report Number
    3005099803-2011-00069
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 28, 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

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISPOSED OF; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE PULLWIRE WAS THREADED THROUGH PERCUTANEOUS STOMA MEASURING DEVICE, (PSMD) AND ATTACHED ONTO ONE STEP DELIVERY SYSTEM WIRE LOOP. THE DELIVERY SYSTEM WIRE LOOP HAD BEEN CUT OFF AND THE REMAINDER OF THE DELIVERY SYSTEM, THE BUTTON AND THE PSMD STYLET WERE NOT RETURNED. 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. THE NYLON COATING OF THE PULLWIRE WAS PEELED DOWN TO WIRE IN MULTIPLE AREAS. PULLWIRE WAS FOUND TO BE KINKED. THREE REMNANTS OF THE PEELED NYLON COATING WERE 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. ADDITIONALLY IT WAS NOTED THAT THE PULLWIRE PRESENTED KINKING. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE OBSERVED DAMAGE IS CONSIDERED OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 13727779 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT.

    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, IT WAS NOTED THE COATING FROM THE PULL WIRE WAS PEELED. NONE OF THE COATING FELL INSIDE THE PATIENT. 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, IT WAS NOTED THE COATING FROM THE PULL WIRE WAS PEELED. NONE OF THE COATING FELL INSIDE THE PATIENT. 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 M00568520 13727779

    Patients

    Seq Age Sex Outcome Treatment
    1