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

Model Number NT-12-19

Device Problems Entrapment of Device (1212); Uncoiled (1659)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/08/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, an epidural catheter was placed within a patient.The first 1mm tip stayed intact but everything behind that came unraveled and stuck in patient's sacrococcyx.Patient had to be opened up to remove the device.Patient status was good after the procedure, having minimal injury.

Manufacturer Narrative

The epidural catheter underwent visual inspection upon return ((b)(4) 2014).It was found that the safety ribbon that assures the coil will stay tight was broken.However, the first few millimeters of the distal tip of the catheter were not unraveled, indicating there was a point of force where the unraveling commenced.(b)(4).

• Brand Name: NEUROTHERM EPIDURAL CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): NEUROTHERM, INC.; wilmington MA
• Manufacturer Contact: 600 research dr; ste 1; wilmington, MA 01887 ; 9786576519
• MDR Report Key: 3893983
• MDR Text Key: 4545971
• Report Number: 3002953813-2014-00003
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: NT-12-19
• Device Lot Number: 120331-1E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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