BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-KATH

    MDR report key: 6908490 · Received October 2, 2017

    Report

    Report Number
    1316297-2017-00007
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    August 29, 2017
    Report Date
    September 29, 2017
    Manufacturer
    EPIMED INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K023140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, THE ACCOUNT REPORTED THAT THE PHYSICIAN WAS DOING A CERVICAL ESI WITH AN EPIMED VERSA-KATH AND AN 18G RX COUDE. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE CATHETER HE FOUND THAT IT STARTED TO UNRAVEL. HE INSPECTED THE CATHETER AND FELT LIKE HE WAS ABLE TO GET ALL OF THE METAL (SPRING COIL) OUT, BUT WANTED EPIMED TO EXAMINE THE DEVICE TO DETERMINE IF ANY OF THE CATHETER'S COATING MAY HAVE BEEN SHEARED OFF. UPON RETURN TO EPIMED, THE DEVICE WAS EXAMINED. IT WAS DETERMINED THAT 3/16" OF THE CATHETERS OUTER COATING WAS MISSING FROM THE DEVICE. THE INTERNAL SPRING REMAINED FULLY INTACT. IT IS SUSPECTED THAT THE CATHETER COATING MAY HAVE SNAGGED ON SCAR TISSUE OR AN INTERNAL STRUCTURE DURING THE PROCEDURE, LEADING TO THE AFOREMENTIONED ISSUE. IT IS ALSO POSSIBLE THAT THE CATHETER COATING BECAME CAUGHT ON THE HEEL OF THE NEEDLE'S BEVEL/TIP AND SUBSEQUENTLY SHEARED. BASED ON THE FINDINGS OF THE INVESTIGATION, EPIMED WILL FOLLOW-UP WITH THE ACCOUNT FOR A PERIOD OF THREE MONTHS TO ENSURE PATIENT SAFETY. AS AN ACT OF GOOD FAITH, EPIMED SUPPLIED THE ACCOUNT WITH A REPLACEMENT VERSA-KATH CATHETER AT NO CHARGE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DOING A CERVICAL ESI WITH AN EPIMED VERSA-KATH AND AN 18G RX COUDE. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE CATHETER HE FOUND THAT IT STARTED TO UNRAVEL. HE INSPECTED THE CATHETER AND FELT LIKE HE WAS ABLE TO GET ALL OF THE METAL (SPRING COIL) OUT, BUT WANTED EPIMED TO EXAMINE THE DEVICE TO DETERMINE IF ANY OF THE CATHETER'S COATING MAY HAVE BEEN SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687876 VERSA-KATH CATHETER BSO EPIMED INTERNATIONAL INC. A-EP-042 11128028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other