FDA Adverse Event
Injury
Summary report: N
VITAL PORT VASCULAR ACCESS SYSTEM
MDR report key: 1032530
·
Received April 22, 2008
Report
- Report Number
- 2522007-2008-00004
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- March 20, 2008
- Report Date
- April 14, 2008
- Manufacturer
- COOK VASCULAR INC.
- Product Code
- LJT
- PMA / PMN Number
- K931586
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: NO CONCLUSION CAN BE DRAWN, DEVICE NOT RETURNED.
Description of Event or Problem · 1
AS REPORTED, "PATIENT EXPERIENCED UNEXPLAINED CHEST PAIN. DETERMINED PORT CATHETER HAD DISCONNECTED (X-RAY) "WRAPPED AROUND HEART." LAST SUCCESSFUL PORT ACCESS IN 2008. THE CATHETER AND PORT WERE REMOVED VIA INTRAVASCULAR RETRIEVAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITAL PORT VASCULAR ACCESS SYSTEM | VITAL PORT | LJT | COOK VASCULAR INC. | IP-S5116W | N63492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |