BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G SPIROL CATHETER

    MDR report key: 7481187 · Received May 2, 2018

    Report

    Report Number
    1316297-2018-00002
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 13, 2018
    Report Date
    May 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

    UPON RETURN, THE SPIROL CATHETER WAS DECONTAMINATED PER SOP-021 (HANDLING BIOLOGICALLY CONTAMINATED PRODUCT). NEXT, THE RETURNED CATHETER WAS EXAMINED. 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 1/8" OF THE CATHETER'S DISTAL END COATING WAS SHEARED OFF FROM THE DEVICE. THE CATHETER'S INTERNAL SPRING WAS STRETCHED UPON RETURN TO EPIMED, BUT REMAINED INTACT. NEXT, THE RETURNED CATHETER WAS EXAMINED USING THE CE-180 (RAM OPTICAL MEASUREMENT SYSTEM). DURING THIS EXAMINATION, IT WAS DISCOVERED THAT THE DIRECTION OF THE COATING SHEAR WAS FROM THE PROXIMAL END OF THE CATHETER TRACKING TOWARDS THE CATHETER'S DISTAL END (SEE ATTACHMENT #1). A CUT WAS ALSO OBSERVED APPROXIMATELY 1" FROM THE CATHETER'S DISTAL END. BECAUSE THE DAMAGE TO THE CATHETER BEGAN APPROXIMATELY 1" FROM THE CATHETER'S DISTAL END AND TRACKED TOWARDS THE CATHETER'S DISTAL TIP, EPIMED SUSPECTS THAT THE DAMAGE MOST LIKELY DERIVED FROM THE CATHETER BEING WITHDRAWN WHILE THE NEEDLE WAS STILL IN PLACE. THIS IS HIGHLIGHTED IN EPIMED'S IFU PI-001 REV. 1 (SPIROL EPIDURAL CATHETER PRODUCTS) § "CAUTION: 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." THE REPORTING ACCOUNT STATED THAT THE PHYSICIAN ADVANCED THE CATHETER WITH THE STYLET PAST THE TUOHY NEEDLE TIP AND WHEN HE PULLED THE CATHETER BACK THE NEEDLE SHEARED THE CATHETER. THIS CONFIRMS EPIMED'S SUSPICIONS THAT THE DAMAGE TO THE CATHETER DERIVED FROM THE PHYSICIAN WITHDRAWING THE CATHETER WHILE THE NEEDLE WAS STILL IN PLACE. THE TUOHY NEEDLE THAT WAS USED IN THE REPORTED COMPLAINT WAS NOT RETURNED TO EPIMED FOR INVESTIGATION. ON APRIL 17, 2018, EPIMED EMAILED (B)(6) REQUESTING LOT INFORMATION FOR THE PRODUCT IN QUESTION. HOWEVER, (B)(6) RESPONDED TO EPIMED THAT NO LOT INFORMATION WAS AVAILABLE. DUE TO THE NATURE OF THE REPORTED COMPLAINT, EPIMED HAS FILED AN MDR (1316297-2018-00002) WITH THE FDA DOCUMENTING THIS INCIDENT. EPIMED WILL FOLLOW UP (B)(6) FOR A PERIOD OF THREE CONSECUTIVE MONTHS IN ORDER TO MONITOR PATIENT HEALTH STATUS. IN ADDITION, EPIMED HAS SUGGESTED TO (B)(6) THAT THE PATIENT INVOLVED IN THIS COMPLAINT CONSULT WITH A NEUROSURGEON FOR ANY RECOMMENDATIONS REGARDING THE PIECE OF CATHETER THAT WAS REPORTED TO BE LEFT INSIDE THE PATIENT'S BODY. BASED ON THE AVAILABLE EVIDENCE, EPIMED HAS DETERMINED THAT THE CATHETER WAS WITHDRAWN WHILE THE NEEDLE WAS STILL IN PLACE, SUBSEQUENTLY CAUSING THE DAMAGE TO THE CATHETER.

    Description of Event or Problem · 1

    ON APRIL 13, 2018, EPIMED'S OEM ACCOUNT, (B)(6), REPORTED THE FOLLOWING TO EPIMED: A PHYSICIAN REPORTED THAT A CATHETER SHEARED INSIDE OF A PATIENT DURING A NERVE BLOCK PROCEDURE. WRITER CONTACTED SALES REP FOR ADDITIONAL INFORMATION AND SAMPLE RETURN. THE SURGEON DECIDED TO LEAVE THE BROKEN CATHETER PIECE IN PLACE WITH NO CONCERNS. THERE WAS ONLY ABOUT HALF A CENTIMETER WAS LEFT IN THE PATIENT. DR. (B)(6) (ANESTHESIOLOGIST) ADVANCED THE CATHETER WITH STYLET PAST THE TUOHY TIP NEEDLE AND ONCE HE PULLED IT BACK THE NEEDLE SHEARED THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323290 20G SPIROL CATHETER CATHETER BSO EPIMED INTERNATIONAL INC A-EP-098 NO LOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other