FDA Adverse Event
Malfunction
Summary report: N
TRIMPORT IMPLANTABLE VASCULAR
MDR report key: 125456
·
Received October 2, 1997
Report
- Report Number
- 1222629-1997-90002
- Event Type
- Malfunction
- Date Received
- October 2, 1997
- Date of Event
- August 22, 1997
- Manufacturer
- GERARD MEDICAL, INC.
- Product Code
- LJT
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE PREVIOUSLY REFERENCED DEVICE HAD BEEN EXPLANTED FROM THE PATIENT. THE DEVICE HAD BEEN IMPLANTED ONE AND A HALF YEARS AGO ON FEBRUARY 22, 1996. THE DEVICE WAS RECEIVED AT GERARD MEDICAL ON SEPTEMBER 15, 1997 FOR ANALYSIS. CO OBSERVED THAT THE CATHETER, WHICH MEASURED 7.5" LONG, HAD COMPLETELY TORN FROM THE PORTAL. THE CATHETER PIECE WAS ALMOST TOTALLY BLOCKED WITH BLOOD CLOTS WHICH WOULD HAVE PROBABLY MADE THE DEVICE UNUSABLE. DUE TO THE SIGNIFICANT BLOOD CLOTS IN THE CATHETER CO DETERMINED THAT THE DEVICE WAS NOT PROPERLY FLUSHED AND MAINTAINED. WHEN NOT IN USE THE DEVICE IS TO BE FLUSHED EVERY 4 WEEKS WITH 5CC HEPARINIZED SALINE (10-100 I.U./CC) TO MAINTAIN PATENCY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMPORT IMPLANTABLE VASCULAR Implant | ACCESS SYSTEM | LJT | GERARD MEDICAL, INC. | * | 238037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |