BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE® SAFETY PEG KIT

    MDR report key: 3070407 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-02974
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICAL ANALYSIS REVEALED THAT THE BALL WELD HAD DETACHED, AND THE COIL WIRE UNRAVELED OFF THE CORE WIRE. THE CORE WIRE WAS UNBROKEN AND WAS MEASURED TO BE APPROXIMATELY 289 CM LONG; OVERALL LENGTH SPECIFICATION FOR THE GUIDEWIRE IS (B)(4). IT WAS NOTED THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE GUIDEWIRE COIL WIRE UNRAVELED. BECAUSE THE WIRE PRESENTED WAS DAMAGED AND ONE BALL WELD WAS NOT RETURNED FOR EVALUATION, IT REMAINS UNKNOWN IF THE CORE WIRE FAILURE OCCURRED DUE TO SUPPLIER QUALITY, CUSTOMER HANDLING/PREP OF THE DEVICE OR PROCEDURAL FACTORS. THEREFORE THE MOST PROBABLE ROOT CAUSE IS 'UNDETERMINABLE'. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 15929885 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 15929885.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF WIRE UNRAVELED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE KINKED WHEN IT WAS ADVANCED. HOWEVER, ON (B)(4) 2013, PHOTOS WERE SENT TO BOSTON SCIENTIFIC SHOWING THAT THE GUIDEWIRE UNRAVELED. THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN COULD NOT TRANSLUMINATE DUE TO A HIATAL HERNIA THAT WAS DISCOVERED DURING THE PROCEDURE. THE HIATAL HERNIA WAS A PRE-EXISTING CONDITION AND WAS NOT CAUSED BY THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE KINKED WHEN IT WAS ADVANCED. HOWEVER, ON (B)(6) 2013, PHOTOS WERE SENT TO BOSTON SCIENTIFIC SHOWING THAT THE GUIDEWIRE UNRAVELED. THE PROCEDURE WAS NOT COMPLETED AS THE PHYSICIAN COULD NOT TRANSILLUMINATE DUE TO A HIATAL HERNIA THAT WAS DISCOVERED DURING THE PROCEDURE. THE HIATAL HERNIA WAS A PRE-EXISTING CONDITION AND WAS NOT CAUSED BY THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171170 ENDOVIVE® SAFETY PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566490 15929885

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR