BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE? SAFETY PEG KIT

    MDR report key: 3943691 · Received July 18, 2014

    Report

    Report Number
    3005099803-2014-02477
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE SNARE FOUND THE WORKING LENGTH BENT ADJACENT TO THE DISTAL END OF THE STRAIN RELIEF AND THE HANDLE CANNULA DETACHED FROM THE HANDLE ASSEMBLY. THE CANNULA WAS FOUND TO BE PUSHED DISTALLY, MOST LIKELY FROM AN ATTEMPT BY THE USER TO FUNCTION THE DEVICE. THE HANDLE CANNULA WAS FOUND TO BE PROPERLY CRIMPED AT APPROXIMATELY 2 MILLIMETERS FROM THE PROXIMAL END SECURING THE CABLE INSIDE THE CANNULA AND SCORE MARKS FROM THE CAP SCREW WERE VISIBLE ON THE CANNULA. THE CANNULA WAS MEASURED TO BE WITHIN SPECIFICATION. THE SOCKET HEAD CAP SCREW WAS INSIDE THE FINGER RING AND TORQUED INTO THE ACTIVE CORD INSERT. THE GAP INSIDE THE INSERT AND UNDER THE SET SCREW WAS PIN GAUGED AND MEASURED TO BE APPROXIMATELY .047 INCH. THE TIP OF THE SCREW AND THE SCREW THREADS PRESENTED SOME DAMAGE. THE SCREW THREAD LENGTH WAS MEASURED TO BE 0.414602 INCH. AN EXAMINATION OF THE INSERT FOUND THE THREADS PRESENTED SOME DAMAGE. IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE SNARE WOULD NOT EXTEND/RETRACT. BASED ON ALL GATHERED INFORMATION THE INVESTIGATION FAILS TO DETERMINE A DEFINITE ROOT CAUSE. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT NUMBER 16874138 WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE REPORTED COMPLAINT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF DIFFICULTY IN CLOSING THE SNARE. 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 DURING A GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY NOTICED THAT THE SNARE LOOP WAS UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD. 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 AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY NOTICED THAT THE SNARE LOOP WAS UNABLE TO CLOSE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PULL METHOD. 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
    421893 ENDOVIVE? SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566521 16874138

    Patients

    Seq Age Sex Outcome Treatment
    1