BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIMED VERSA-KATH

    MDR report key: 5197267 · Received November 2, 2015

    Report

    Report Number
    1316297-2015-00004
    Event Type
    Malfunction
    Date Received
    November 2, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 27, 2015
    Product Code
    BSO
    PMA / PMN Number
    954584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    PER EPIMED'S INVESTIGATION, EPIMED BELIEVES THAT THE CATHETER IN QUESTION WAS DAMAGED AS A RESULT OF THE PHYSICIAN'S TECHNIQUE. THE ACCOUNT REPORTED THAT THE (TUOHY) NEEDLE REMAINED IN PLACE DURING INITIAL REMOVAL OF THE CATHETER IN QUESTION. RESISTANCE WAS EXPERIENCED BY THE PHYSICIAN DURING CATHETER WITHDRAW. EPIMED DETERMINED THAT APPROXIMATELY 2.0CM OF THE CATHETER'S OUTER (FEP) COATING SHEARED OFF WITHIN THE PATIENT DURING THIS TIME. EPIMED WARNS AGAINST THIS PRACTICE WITHIN THEIR VERSA-KATH IFU (PI-048 REV. 0), PRECAUTION #5 STATES, "DURING CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED, STOP, REPOSITION THE PATIENT TO OPEN THE VERTEBRAL INTERSPACES AND ATTEMPT REMOVAL. IF FURTHER DIFFICULTY IS ENCOUNTERED, FLUOROSCOPY OR X-RAY MAY BE INDICATED PRIOR TO FURTHER CATHETER MANIPULATION." ALSO, EPIMED WARNS AGAINST LEAVING THE NEEDLE IN PLACE DURING REMOVAL OF THE CATHETER WITHIN THEIR IFU (PI-048), STATING: "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." REGARDLESS ONCE RESISTANCE WAS FELT, THE PHYSICIAN TOOK APPROPRIATE MEASURES AND REMOVED THE CATHETER AND NEEDLE TOGETHER AS A UNIT. EPIMED BELIEVES IF THE (PI-048) VERSA-KATH'S IFU WAS FOLLOWED IN COMBINATION WITH USING THE PACKAGE SUGGESTED INTRODUCER NEEDLE, IT MAY HAVE PREVENTED DAMAGE TO THE CATHETER.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE ACCOUNT WAS PERFORMING A CAUDAL EPIDURAL STEROID INJECTION. WHILE REMOVING THE NEEDLE AND CATHETER AS A UNIT, RESISTANCE WAS EXPERIENCED. AS THE CATHETER CAME OUT THE INTERNAL SPRING BEGAN TO UNRAVEL. ONCE THE CATHETER WAS REMOVED, THE ACCOUNT REALIZED THAT THE VERSA-KATH SHEARED, LEAVING APPROXIMATELY 1CM OF MATERIAL WITHIN THE PATIENT. THE ENTIRE CATHETER WAS REMOVED, BESIDES THE 1CM PIECE OF MATERIAL. THE PATIENT IS CURRENTLY DOING WELL. HOWEVER, DR. DIAZ-RAMIREZ HAS CONTACTED A NEUROSURGEON TO DISCUSS THE POSSIBILITY OT REMOVING THE REMAINING PIECE OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725291 EPIMED VERSA-KATH VERSA-KATH BSO A-EP-042 11127041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention