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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX CONTINUOUS EPIDURAL CATHETER

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SMITHS MEDICAL ASD, INC. PORTEX CONTINUOUS EPIDURAL CATHETER Back to Search Results
Model Number 8024-20
Device Problems Break (1069); Kinked (1339); Difficult to Remove (1528)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Date 07/25/2017
Event Type  Injury  
Event Description
The pt had his lumbar epidural steroid inspection earlier today. I would like to go over the events leading to almost certain epidural catheter fragment broken off in his epidural space. There were 2 attempts to do the epidural steroid injection on the pt done via caudal approach using fluoroscopy. On the first attempt, the needle was placed into the epidural space via caudal approach and the epidural catheter was fed through the needle and was noted to be appropriate on fluoroscopy, and therefore, the wire was removed and i attempted to inject the isovue-m-200 dye. It was very difficult to do. I pulled back both needle and catheter at the same time a short distance and it was still very difficult to inject through the catheter. At this point, i decided to just repeat the procedure, and i removed the tuohy needle and catheter at the same time and i noticed that the catheter was only a short distance (approx 1 cm) in front of the tuohy needle. On close inspection, i saw that the catheter had broken and that a fragment was most likely in the in the epidural space. I obtained another epidural catheter from another epidural kit and i placed the needle into the epidural space and fed the catheter up without complication and gave the pt the epidural steroid injection without problem. I decided to proceed since the pt had stopped his plavix and was in significant pain. Upon measuring with the second catheter, the retained fragment was approx 9 cm long. At this point, i immediately went to discuss this with the radiologist, to discuss options and i told him my concern was that i wanted to be sure if the fragment was indeed in the epidural space. I did order a ct scan of the lumbosacral spine and radiologist did feel he could see part of the catheter at the l5-s1 inner space. It was a difficult study because the steroid and dye and 0. 5% lidocaine was still obviously present and radiologist recommended that we repeat it in several days if a more accurate view of the catheter was needed. I immediately went to talk to the pt and his wife and discuss the fact that indeed i was very sure that he did have fragment of a catheter in his epidural space. I told them that while epidural catheter fragments are generally not removed unless symptomatic. I wanted pt to see neurosurgeon in (b)(6). His office reiterated to me that unless the pt gets a problem with new pain that he would not remove it. I have told the pt and his wife this and i have been open with them about this incident. I feel the most likely cause of this incident is kinking of the catheter at the tip of the tuohy needle while inserting it (it should be noted that i did not feel any excessive resistance as compared to previous cases. ) there are a small amount of catheter past the tuohy needle when i pulled the first catheter. This would also explain the difficulty injecting on the first attempt. It is certainly possible the needle tip sheared the catheter while pulling the tuohy needle/catheter out, but that would not explain the catheter tip being approx one cm past the needle tip when removed (or the difficulty injecting through the catheter on the first attempt. ) throughout my career, i have never pulled an epidural catheter backwards through the needle. If that occurred on this occasion, it was inadvertent. Pt and his wife both understand the situation, and i have answered their questions. I am going to make sure that they get an office visit scheduled with neurosurgeon ((b)(6) 2017 at 8:00 am) who wants to see them just so that he will know him if any problems do arise in the future.
 
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Brand NamePORTEX
Type of DeviceCONTINUOUS EPIDURAL CATHETER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
keene NH 03431
MDR Report Key6776784
MDR Text Key82397137
Report NumberMW5071452
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/13/2018
Device Model Number8024-20
Device Lot Number3288475
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/07/2017 Patient Sequence Number: 1
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