MAUDE Adverse Event Report: NEUROTHERM, INC. NEUROTHERM EPIDURAL CATHETER; DISPOSABLE EPIDURAL CATHETER

Model Number NT-12-19

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2014

Event Type  Injury  

Event Description

Near the end of the procedure, the introducer needle and epidural catheter were removed simultaneously.It was noted the epidural catheter may have stretched slightly and may have caught on some fibrous tissue within the sacrum.An x-ray was performed, which revealed a small shade around s2-3.A ct scan was scheduled to investigate this finding.The patient was followed on a daily basis and no adverse reaction was noted.

• Brand Name: NEUROTHERM EPIDURAL CATHETER
• Type of Device: DISPOSABLE EPIDURAL CATHETER
• Manufacturer (Section D): NEUROTHERM, INC.; wilmington MA
• Manufacturer Contact: 600 research drive; suite 1; wilmington, MA 01887 ; 9786576519
• MDR Report Key: 4337389
• MDR Text Key: 5173368
• Report Number: 3002953813-2014-00015
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K050557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: NT-12-19
• Device Lot Number: 121130-1A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other