FDA Adverse Event
Other
Summary report: N
CHEMO-PORT
MDR report key: 547655
·
Received October 7, 2004
Report
- Report Number
- 2925153-2004-00020
- Event Type
- Other
- Date Received
- October 7, 2004
- Date of Event
- September 24, 2004
- Report Date
- September 27, 2004
- Manufacturer
- HDC CORP.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
"A PT HAD A PORT INSERTED 6 WEEKS AGO. TODAY PT PRESENTED WITH THE DISTAL 10CM FRACTURED OFF AND LODGED IN THE RIGHT VENTRICLE WITH THE REMAINING PORT AND LINE IN PLACE. PT DID HAVE A RATHER NARROW SPACE BETWEEN THE FIRST AND CLAVICLE ON INSERTION, AND DR PRESUMES THE SCISSORS ACTION OF THE TWO AGAINST THE LINE PORTION OF THE PORT, CUT IT IN TWO AND IT FLOATED DOWNSTREAM. THE SEVERED END OF THE PORT WAS REMOVED BY CATHETER SNARE IN AN ANGIOGRAPHY SUITE. THE PORT WILL NOT BE REMOVED FULLY UNTIL THE BLEEDING RISK IS REDUCED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHEMO-PORT | * | LJT | HDC CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |