BEUDAMED
    FDA Adverse Event Other Summary report: N

    MYELOTEC NAVICATH STEERABLE EPIDURAL CATHETER

    MDR report key: 980565 · Received January 11, 2008

    Report

    Report Number
    1062474-2007-07071
    Event Type
    Other
    Date Received
    January 11, 2008
    Manufacturer
    MYELOTEC, INC.
    Product Code
    BSO
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM VERBAL DESCRIPTION OF THE INCIDENT FROM THE FACILITY, IT WAS INITIALLY SPECULATED THAT A SEPARATION HAD OCCURRED IN THE PROXIMAL WELD JOINT BETWEEN SHAFT MATERIALS, BUT THAT THE CATHETER WAS INTACT. NO OTHER CATHETERS HAVE BEEN REPORTED TO MANUFACTURER WITH THIS PROBLEM. DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, SO NO DETERMINATION OF CAUSE FOR INCIDENT COULD BE OFFERED. THREE CATHETERS FROM THE SAME LOT AS INCIDENT CATHETER WERE EXAMINED TO DETERMINE IF ANY OF THESE CATHETERS HAD A SEPARATION, OR COULD BE INDUCED TO SEPARATE, AT THIS WELD JOINT. EACH OF THESE THREE CATHETERS WAS VISUALLY INSPECTED UNDER MAGNIFICATION AND THE WELD JOINT IN QUESTION WAS PHOTOGRAPHED. EACH CATHETER WAS THEN LOADED WITH A GUIDE WIRE TO PROVIDE RESISTANCE AND CYCLE TESTED AS IS PERFORMED IN FINAL INSPECTION OF THE PRODUCT BEFORE RELEASE TO PACKAGING. EACH CATHETER WAS REINSPECTED AND PHOTOGRAPHED AFTER EACH OF THREE SUCH CYCLE TESTING PROCEDURES. NO FAILURES OF THE SUSPECTED WELD JOINT COULD BE PRODUCED AFTER THESE CYCLE TESTING PROCEDURES. PRODUCTION LOT RECORDS FOR THE DEVICE WERE EXAMINED AND ALL SET-UP LOGS AND INSPECTION LOGS WERE COMPLETED APPROPRIATELY PER DEVICE SPECIFICATIONS. NO CAUSE CAN BE DETERMINED AT THIS TIME WITHOUT RECEIPT OF THE CATHETER FROM THE FACILITY FOR EVALUATION.

    Description of Event or Problem · 1

    INITIAL REPORT FROM FACILITY INDICATED THAT DURING A PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY IN REMOVING A NAVICATH CATHETER FROM A PT. THE CATHETER HAD PERFORMED TO SPECIFICATIONS DURING THE PROCEDURE. HOWEVER, WHILE WITHDRAWING THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN PERFORMED A SMALL STAB INCISION AT THE INSERTION SITE AND WAS ABLE TO REMOVE THE CATHETER COMPLETELY. THE PT WAS RECOVERED ACCORDING TO NORMAL FACILITY PROTOCOL AND NO FURTHER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYELOTEC NAVICATH STEERABLE EPIDURAL CATHETER EPIDURAL CATHETER BSO MYELOTEC, INC. 2017 1551/MT14507

    Patients

    Seq Age Sex Outcome Treatment
    1