BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROL

    MDR report key: 7927699 · Received October 2, 2018

    Report

    Report Number
    1316297-2018-00011
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 2, 2018
    Manufacturer
    EPIMED INTERNATIONAL INC
    Product Code
    BSO
    PMA / PMN Number
    K981329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER'S DISTAL TIP COATING AND INTERNAL SPRING WERE SHEARED OFF FROM THE DEVICE. MEASUREMENT TESTING WAS CONDUCTED AND IT WAS DETERMINED THAT APPROXIMATELY 50MM OF THE CATHETER'S DISTAL END COATING WAS SHEARED OFF FROM THE DEVICE. IN ADDITION, APPROXIMATELY 20-30MM OF THE CATHETER'S INTERNAL SPRING WAS ALSO SHEARED OFF FROM THE DEVICE. THE SHEARED PORTION OF THE CATHETER WAS NOT RETURNED TO EPIMED. WITHIN THE COMPLAINT DESCRIPTION PROVIDED TO EPIMED, THE ACCOUNT REPORTED THAT, "THE CATHETER WAS TUNNELED THROUGH THE FASCIA BUT THE CATHETER WAS INSERTED BACKWARDS UP THE NEEDLE WHICH THE DOCTOR BELIEVES IT WAS SHEARED WHILE DOING SO." A TUNNELING PROCEDURE CAN BE CONDUCTED BY INSERTING THE DISTAL TIP OF THE CATHETER INTO AN INCISION ON THE PATIENT CLOSE TO THE NERVE. AFTER DOING THIS, THE NEEDLE IS THEN INSERTED INTO THE PATIENT AT AN AREA ON THE BODY THAT IS AWAY FROM THE FIRST INCISION; TYPICALLY SEVERAL INCHES OR MORE. THE NEEDLE IS THEN PUSHED UNDER THE SKIN TO A POINT WHERE THE NEEDLE TIP AGAIN PUNCTURES AND PASSES THROUGH THE SKIN; WHERE THE DISTAL TIP OF THE NEEDLE NOW PROTRUDES FROM THE BODY. THE PROXIMAL END OF THE CATHETER IS THEN THREADED THROUGH THE DISTAL TIP OF THE NEEDLE AND BACK UP THROUGH THE NEEDLE TO WHERE THE CATHETER IS THEN WITHDRAWN OUT OF THE PROXIMAL END OF THE NEEDLE. ONCE THIS IS COMPLETE, THE NEEDLE AND CATHETER ARE WITHDRAWN THROUGH THE "TUNNEL" CREATED BY THE NEEDLE INSERTION. THE NEEDLE IS THEN REMOVED, LEAVING THE CATHETER SECURED WITHIN THE PATIENT, UNDER THE PATIENT'S SKIN. EPIMED'S IFU (B)(4) (SPIROL EPIDURAL CATHETER PRODUCTS) CAUTION STATES, "IF EXCESSIVE RESISTANCE IS ENCOUNTERED, STOP, REMOVE BOTH NEEDLE AND CATHETER AS A UNIT AND ATTEMPT NEW PUNCTURE. TO AVOID SHEARING CATHETER, NEVER WITHDRAW CATHETER BACK AGAINST NEEDLE BEVEL." BASED ON THE TUNNELING TECHNIQUE DESCRIBED AS BEING USED BY THE PHYSICIAN, EPIMED HAS DETERMINED THAT THE END-USER FAILED TO PROPERLY FOLLOW EPIMED'S IFU REGARDING THE INSTRUCTION TO "NEVER WITHDRAW THE CATHETER BACK AGAINST THE NEEDLE BEVEL."

    Description of Event or Problem · 1

    "THE ANESTHESIOLOGIST THAT PERFORMED THE BLOCK INFORMED HIM THAT A CATHETER WAS SHEARED. A FASCIA ILIACA BLOCK WAS PERFORMED. THE CATHETER WAS TUNNELED THROUGH THE FASCIA BUT THE CATHETER WAS INSERTED BACKWARDS UP THE NEEDLE WHICH THE DOCTOR BELIEVES IT WAS SHEARED WHILE DOING SO. THEREFORE, THERE WAS A POSSIBILITY THAT THE CATHETER WAS ALREADY SHEARED WHILE IN THE PATIENT. THEY NOTICED THAT THE CATHETER WAS SHEARED WHEN THE CATHETER WAS REMOVED. THE ANESTHESIOLOGIST BELIEVES THERE 'POSSIBLY' COULD BE A SMALL PIECE OF THE CATHETER IN THE PATIENT BUT IS UNSURE. AT THIS TIME, THEY WILL NOT BE DOING ANY MEDICAL INTERVENTIONS TO CONFIRM IF THERE ARE ANY PIECES LEFT IN THE PATIENT AND OR REMOVE ANY PIECES THAT MAY HAVE BEEN LEFT. THE PATIENT IS IN STABLE CONDITION AND THERE WAS NO PATIENT INJURY REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768920 SPIROL CATHETER BSO EPIMED INTERNATIONAL INC A-EP-098 NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other