FDA Adverse Event
Injury
Summary report: N
NEUROTHERM EPIDURAL CATHETER
MDR report key: 3893983
·
Received June 10, 2014
Report
- Report Number
- 3002953813-2014-00003
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- May 8, 2014
- Report Date
- May 12, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- BSO
- PMA / PMN Number
- K050557
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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).
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343428 | NEUROTHERM EPIDURAL CATHETER | EPIDURAL CATHETER | BSO | NEUROTHERM, INC. | NT-12-19 | 120331-1E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |