MAUDE Adverse Event Report: NEUROTHERM, INC NEUROTHERM¿ EPIDURAL CATHETER, 19G, 18 INCH; CATHETER, CONDUCTION, ANESTHETIC

Model Number NT-18-19

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590); Material Deformation (2976)

Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During an epidural neurolysis (racz) procedure, the tip of the epidural catheter detached.While removing the catheter from the epidural space, it was felt the catheter had a potential fracture.The epidural needle was removed and gentle traction was applied to the catheter, which resulted in the shaft of the catheter unraveling.An incision was made in an attempt to remove the catheter; however, this was unsuccessful and further dissection down to the sacrococcygeal ligament was performed.It was noted the catheter fragment was still intact within the epidural space and a decision was made to leave the fragment in place as the patient was neurologically asymptomatic and was likely to tolerate the fragment remaining.The incision was closed and the patient was discharged on antibiotics.

Manufacturer Narrative

(b)(4).Maude report form: mw5060627.One neurotherm epidural catheter with stylet was returned for evaluation.The results of the investigation concluded that the distal tip of the catheter was fractured from shaft of the catheter; functional testing could not be performed due to the aforementioned damage.The cause of the reported event could not be conclusively determined.The device was manufactured according to specifications as supported by the device history record.

• Brand Name: NEUROTHERM¿ EPIDURAL CATHETER, 19G, 18 INCH
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer (Section G): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5519348
• MDR Text Key: 40940123
• Report Number: 3002953813-2016-00012
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Model Number: NT-18-19
• Device Lot Number: 9800990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other