BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ SAFETY PEG KIT

    MDR report key: 2840051 · Received November 20, 2012

    Report

    Report Number
    3005099803-2012-05301
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF LOOP ON THE END OF THE PEG TUBE BROKE. 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

    A VISUAL EXAMINATION OF THE DEVICE FOUND THE SILICONE TUBING TO HAVE BEEN CUT AT APPROXIMATELY 2.8 CM PROXIMAL THE OUTER RING. NO ISSUES WERE NOTED WITH THE TUBING, CONNECTOR AND INNER AND OUTER RINGS. THE DISTAL PORTION OF THE DEVICE WAS NOT RETURNED. AN EXAMINATION OF THE DILATING TIP FOUND THE WIRE LOOP TO BE COMPLETELY DETACHED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT NUMBER 15398301 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMING EVENTS OR DEVIATIONS IDENTIFIED IN THE DHR REVIEW. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE PHYSICIAN PULLED THE PEG TUBE THROUGH THE STOMA SITE, THE LOOP ON THE END OF THE PEG TUBE BROKE, OUTSIDE THE STOMACH WALL. THE PHYSICIAN USED A HEMOSTAT TO GRASP THE TIP OF THE PEG AND TO PULL IT INTO PLACE TO COMPLETE THE PROCEDURE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (DATE IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE PHYSICIAN PULLED THE PEG TUBE THROUGH THE STOMA SITE, THE LOOP ON THE END OF THE PEG TUBE BROKE, OUTSIDE THE STOMACH WALL. THE PHYSICIAN USED A HEMOSTAT TO GRASP THE TIP OF THE PEG AND TO PULL IT INTO PLACE TO COMPLETE THE PROCEDURE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE¿ SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566460 15398301

    Patients

    Seq Age Sex Outcome Treatment
    1