BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-KATH

    MDR report key: 6602318 · Received May 31, 2017

    Report

    Report Number
    1316297-2017-00005
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 12, 2017
    Report Date
    May 31, 2017
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K954584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON JUNE 13, 2017, EPIMED'S QA ANALYST EMAILED (B)(6) REQUESTING AN UPDATE ON THE PATIENT STATUS. (B)(6) STATED THAT THE PATIENT SAW A NEUROSURGEON AS RECOMMENDED BY EPIMED AND NO INTERVENTIONS WERE PLANNED AT THIS TIME. PATIENT HAS NOT FOLLOWED UP DR. (B)(6) OFFICE SINCE THE ORIGINAL FOLLOW-UP ON (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO EPIMED, BOTH THE NEEDLE AND CATHETER WERE EXAMINED. THE SHEARED PROXIMAL PORTION OF THE CATHETER WAS OUTSIDE THE PROXIMAL END OF THE NEEDLE UPON RETURN, WITH ONLY THE INTERNAL SPRING LEFT INSIDE THE NEEDLE. EPIMED'S QA ANALYST WAS ABLE TO PULL THE CATHETER'S PROXIMAL PORTION BACK THROUGH THE NEEDLE IN ORDER TO EXAMINE. IT WAS NOTICED THAT THE CATHETER SHEAR TRACKED FROM THE CATHETER'S PROXIMAL END TO ITS DISTAL END, AND THE INITIAL CUT IN THE COATING IS CONTAINED TO ONE SIDE OF THE CATHETER. THIS SUGGESTS THAT THE CATHETER BECAME CAUGHT ON THE HEEL OF THE NEEDLE'S BEVEL/TIP AND THE SUBSEQUENT FULL WITHDRAWAL OF THE CATHETER SHEARED APPROXIMATELY 3.9 INCHES OF THE CATHETER'S COATING OFF FROM THE DEVICE. EPIMED'S IFU PI-003 REV. 2 (EPIDURAL NEEDLE PRODUCTS) SUBSECTION WARNINGS STATES: "2. DO NOT REMOVE CATHETER WHILE NEEDLE IS IN PLACE. SPRING GUIDE CATHETER AND EPIDURAL NEEDLE MUST BE REMOVED TOGETHER AS A UNIT TO PREVENT POTENTIAL CATHETER DAMAGE." THE COMPLAINT REPORT STATED THAT THE PHYSICIAN DID NOT DRAW BACK ON THE CATHETER WHILE THE NEEDLE WAS STILL IN PLACE; HOWEVER, AFTER INSPECTING THE RETURNED CATHETER AND NEEDLE, THE DAMAGE TO THE CATHETER IS INDICATIVE OF THIS HAPPENING. EPIMED WILL FOLLOW UP WITH THE ACCOUNT FOR A PERIOD OF 3 MONTHS TO ENSURE PATIENT SAFETY. A FULL COMPLAINT REPORT WILL BE ATTACHED TO THE FIRST MDR UPDATE TO BE COMPLETED BY 6/12/2017.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE ACCOUNT REPORTED, "WHEN REMOVING NEEDLE AND CATHETER THERE WAS RESISTANCE AND PART OF THE CATHETER DETACHED IN THE EPIDURAL SPACE. THE METAL COIL WAS FULL WITHDRAWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381758 VERSA-KATH CATHETER BSO EPIMED INTERNATIONAL INC. A-EP-042 11127919

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other