BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE? SAFETY PEG KIT

    MDR report key: 3173652 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05001
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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

    A VISUAL EXAMINATION OF THE DEVICE REVEALED THAT ONE OF THE CLAMPING ARMS OF THE HEMOSTAT WAS FOUND TO BE BROKEN AT THE BASE. THE BROKEN ENDS WERE OBSERVED UNDER A MICROSCOPE AND NO VOIDS OR DEFECTS THAT COULD HAVE CAUSED THE BREAKAGE WERE FOUND. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE HEMOSTATS WERE BROKEN. THE MOST LIKELY CAUSE OF THIS COMPLAINT IS THAT THE FORCE APPLIED TO THE HEMOSTAT DURING USE WAS ENOUGH TO CAUSE THE ARM TO BREAK. THERE WERE NO DEFECTS FOUND WITH THE HEMOSTAT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE BREAKAGE. DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE PERFORMANCE WAS LIMITED, THEREFORE THE MOST PROBABLE ROOR CAUSE IS OPERATIONAL CONTEXT. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED AND THERE WERE NO NON-CONFORMING EVENTS OR ANY DEVIATIONS IDENTIFIED. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 15675762.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE SAFETY PEG KIT PULL METHOD 20FR WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE OUTSIDE THE PATIENT, WHEN THE PHYSICIAN PLACED THE EXTERNAL BOLSTER ONTO THE PEG TUBE, THE FORCEPS BROKE. THE PROCEDURE WAS COMPLETED WITH THIS PEG 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 ENDOVIVE SAFETY PEG KIT PULL METHOD 20FR WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE OUTSIDE THE PATIENT, WHEN THE PHYSICIAN PLACED THE EXTERNAL BOLSTER ONTO THE PEG TUBE, THE FORCEPS BROKE. THE PROCEDURE WAS COMPLETED WITH THIS PEG 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
    272997 ENDOVIVE? SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566521 15675762

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR