FDA Adverse Event
Injury
Summary report: N
BIOFLEX TESIO
MDR report key: 1111553
·
Received August 13, 2008
Report
- Report Number
- 2518902-2008-00026
- Event Type
- Injury
- Date Received
- August 13, 2008
- Date of Event
- July 9, 2008
- Report Date
- August 6, 2008
- Manufacturer
- MEDCOMP
- Product Code
- MSD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAD BEEN IN THE PATIENT FOR 1.5 YEARS. EXAMINATION OF THE RETURNED PIECES OF CATHETER LUMEN REVEALED NO VISIBLE MATERIAL DETERIORATION. WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH CONTRIBUTED TO THIS EVENT. ALL CATHETERS ARE PRONE TO PHYSIOLOGICAL ENCAPSULATION AND CALCIFICATION.
Description of Event or Problem · 1
THE CATHETER WAS PLACED 2006 AND OWING TO BOTH POOR FLOW AND SEPSIS A DECISION WAS MADE TO REMOVE THE LINE, DONE IN 2008. X-RAY TAKEN SIX DAYS LATER, SHOWED THAT THE TIP OF THE CATHETER HAD DETACHED AND WAS ATTACHED TO THE PT'S HEART VALVE IN THE RIGHT ATRIUM. AN ECHO AND TOE CONFIRMED THE PRESENCE OF A FOREIGN BODY IN THE RIGHT ATRIUM WHICH WAS "INFECTIVE AND VEGETATIVE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOFLEX TESIO | HEMODIALYSIS CATHETER | MSD | MEDCOMP | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R |