FDA Adverse Event
Malfunction
Summary report: N
PROMETRA CATHETER
MDR report key: 3947703
·
Received May 5, 2014
Report
- Report Number
- 3006803715-2014-00008
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Date of Event
- April 7, 2014
- Report Date
- April 7, 2014
- Manufacturer
- FLOWONIX MEDICAL INC.
- Product Code
- LKK
- PMA / PMN Number
- P080012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS DISCARDED; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. INTERNAL COMPLAINT NUMBER: (B)(4).
Description of Event or Problem · 1
THE PATIENT HAD A CATHETER ACCESS PORT STUDY DONE AFTER FALLING TWICE. THE CATHETER ACCESS PORT STUDY SHOWED REDUCED ABILITY TO ASPIRATE CEREBROSPINAL FLUID LEADING THE PHYSICIAN TO BELIEVE THE CATHETER MAY HAVE MOVED OUT OF THE INTRATHECAL SPACE. A CATHETER REVISION SURGERY TOOK PLACE ON 4/17. THE CATHETER WAS REPLACED WITH A NEW ONE AND THE ORIGINAL CATHETER WAS DISCARDED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268073 | PROMETRA CATHETER | IMPLANTABLE INTRATHECAL CATHETER | LKK | FLOWONIX MEDICAL INC. | 11823 | 18730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |