BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE® SAFETY PEG KIT

    MDR report key: 3253116 · Received July 29, 2013

    Report

    Report Number
    3005099803-2013-08043
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE FOUND THAT A PORTION OF THE DOME (INTERNAL BOLSTER) WAS TORN OFF. THE TORN PORTION OF THE DOME WAS NOT RETURNED. THE DOME DID NOT PRESENT ANY MOLDING DEFECTS WHICH MIGHT HAVE CONTRIBUTED TO THIS FAILURE. IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BOTTOM END PART OF THE TUBE WAS CRACKED. THE DOME DID NOT PRESENT ANY MOLDING DEFECTS WHICH MIGHT HAVE CONTRIBUTED TO THIS FAILURE AND THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS. THE ISSUE WAS NOTED DURING PREPARATION AND OUTSIDE THE PATIENT, THEREFORE THE MOST PROBABLE ROOT CAUSE IS ¿HANDLING DAMAGE¿. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT NUMBER 16157158 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE REPORTED COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST LOT NUMBER 16157158.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF FEEDING TUBE TORN/SPLIT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED ON A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IN UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THERE WAS A CRACK AT THE BOTTOM END OF THE PEG TUBE. IT WAS UNKNOWN WHETHER THE CRACK WAS AT THE LOOP END OR THE BOLSTER END OF THE PEG TUBE. THIS DEVICE WAS NOT USED IN THE PATIENT. A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED 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 ON A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IN UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THERE WAS A CRACK AT THE BOTTOM END OF THE PEG TUBE. IT WAS UNKNOWN WHETHER THE CRACK WAS AT THE LOOP END OR THE BOLSTER END OF THE PEG TUBE. THIS DEVICE WAS NOT USED IN THE PATIENT. A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED 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
    352937 ENDOVIVE® SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566480 16157158

    Patients

    Seq Age Sex Outcome Treatment
    1