FDA Adverse Event
Injury
Summary report: N
PORT-A-CATH
MDR report key: 16293
·
Received February 4, 1994
Report
- Report Number
- 16293
- Event Type
- Injury
- Date Received
- February 4, 1994
- Date of Event
- November 16, 1993
- Report Date
- November 19, 1993
- Manufacturer
- PHARMACIA DELTEC, INC.
- Product Code
- LJT
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT ADMITTED ON 11/16/93 FOR ARTERIOGRAM TO RETRIEVE A CATHETER FRAGMENT. FRAGEMENT WAS SUCCESSFULLY RETRIEVED FROM THE RIGHT VENTRICLE. PATIENT HAD SOME VENTRICULAR TACHYCARDIA DURING PROCEDURE. CATHETER WAS REMOVED THROUGH THE RIGHT FEMORAL VEIN BY A RADIOLOGIST.FOLLOW-UPPATIENT RETURNED ON 12/1/93 FOR REMOVAL OF THE REST OF THE PORTACATH. THIS REMOVAL WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORT-A-CATH Implant | VENOUS ACCESS CATHETER | LJT | PHARMACIA DELTEC, INC. | PORTAL PART NO. 69-1944 | PORT-8987 CATH-8104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R |