MAUDE Adverse Event Report: NEUROTHERM NEUROTHERM EPIDURAL CATHETER

Model Number NT-18-19

Device Problems Material Fragmentation (1261); Unraveled Material (1664); Defective Device (2588)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/24/2016

Event Type  malfunction  

Event Description

Pt scheduled for pain management procedure, "racz procedure l4-5, l5-s1".Anesthesiologist advanced catheter through epidural needle, however, as he was retracting the catheter it felt "as it gave slightly, although it was still contiguous".Dr.Became suspicious of a potential catheter break that was incomplete.He removed the rk needle and attempted to put gentle traction on the catheter to remove it.This showed that the catheter fragment in his hand was coming back towards him while the spring loaded interior of the catheter was unraveling indicating the external sheath of the catheter had a defect in it and was unable to be retrieved this way.An incision was then made with an attempt to retrieve the catheter.After dissection to the sacrococcygeal ligament, it was noted that the catheter fragment was still intact and within the epidural space.It was decided that it would not be wise to enter the spinal canal and the embedded catheter fragment would remain, which should be well tolerated and was not causing neurological symptoms.Incision was closed and pt subsequently discharged home with antibiotic.Product used for introduction of epidural catheter: epimed r.K.Epidural needle ref.#(b)(4), lot 12166447, expiration 07-2019.

• Brand Name: NEUROTHERM EPIDURAL CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): NEUROTHERM; wilmington MA
• MDR Report Key: 5470674
• MDR Text Key: 39557756
• Report Number: MW5060627
• Device Sequence Number: 1
• Product Code: BSO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: NT-18-19
• Device Catalogue Number: NT-18-19
• Device Lot Number: 9800990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 97