BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE® STANDARD PEG KIT

    MDR report key: 3233482 · Received July 18, 2013

    Report

    Report Number
    3005099803-2013-06804
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 26, 2013
    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 FEEDING TUBE BLOCKED OCCLUDED. 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A FUNCTIONAL EVALUATION WAS PERFORMED BY ATTEMPTING TO PASS A .035" GUIDEWIRE THROUGH THE DELIVERY SYSTEM. THE GUIDEWIRE WOULD NOT PASS THROUGH THE BARBED CONNECTOR FROM EITHER DIRECTION. THE DEVICE WAS DISASSEMBLED BY CUTTING OFF THE OUTER RING AND THEN REMOVING THE THERMOFORMED TUBING AND SILICONE TUBING FROM THE BARBED CONNECTOR. THE METAL CANNULA OF THE BARBED CONNECTOR WAS FOUND TO BE FULLY OCCLUDED WITH A CLEAR SUBSTANCE ON THE THREADED END OF THE CONNECTOR. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE GUIDEWIRE WOULD NOT PASS THROUGH THE CONNECTOR. THE MATERIAL WAS DETERMINED TO BE CONSISTENT WITH CYANOACRYLATE ADHESIVE. ADHESIVE IS PLACED ON THE BARBED CONNECTOR DURING THE MANUFACTURING ASSEMBLY PROCESS, THEREFORE THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE  REPORTED LOT NUMBER 15663410.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS AN OBSTRUCTION AT THE TRANSITION ZONE IN THE PEG TUBE THAT WOULD NOT ALLOW THE TUBE TO BE TRACKED OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG KIT PUSH 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 OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS AN OBSTRUCTION AT THE TRANSITION ZONE IN THE PEG TUBE THAT WOULD NOT ALLOW THE TUBE TO BE TRACKED OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG KIT PUSH 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 OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333527 ENDOVIVE® STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568211 15663410

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR