FDA Adverse Event
Malfunction
Summary report: N
PROMETRA CATHETER
MDR report key: 5051010
·
Received September 2, 2015
Report
- Report Number
- 3006803715-2015-00060
- Event Type
- Malfunction
- Date Received
- September 2, 2015
- Date of Event
- August 5, 2015
- Report Date
- August 6, 2015
- Manufacturer
- FLOWONIX MEDICAL, INC
- Product Code
- LKK
- PMA / PMN Number
- P080012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: VISUAL INSPECTION WAS PERFORMED ON THE RETURNED CATHETER. THE REPORTED EVENT WAS CONFIRMED. THE CATHETER DAMAGE WAS REPRODUCED AT FLOWONIX USING A DEMO CATHETER. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2015, A CATHETER REVISION SURGERY WAS PERFORMED TO REPLACE THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CATHETER ACCESS PORT DYE STUDY, THE CATHETER WAS OBSERVED TO BE LEAKING MIDWAY. NO PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580987 | PROMETRA CATHETER | IMPLANTABLE INTRATHECAL CATHETER | LKK | FLOWONIX MEDICAL, INC | 11823 | 18730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |