OtherGBW
*
Received Dec 4, 2003 · Event occurred Jun 2, 2003
Report 3001587388-2003-00023 · MDR key 501635
Device
Product problems
- Explanted
- Device, or device fragments remain in patient
- Cut In Material
Patient
UNKNOWN
- Nonresorbable materials, unretrieved in body
- Surgical procedure
Narrative
Description of Event or Problem
IMPLANTATION OF A SOPHYSA SHUNT IN 1999 INCLUDING A SOPHY SM8 ADJUSTABLE VALVE, A VENTRICULAR CATHETER WITH LEROY RESERVOIR (CAT. #PL06) AND PERITONEAL CATHETER (CAT. #B905S). IN MAY 2003, THE NEUROSURGEON NOTED THAT: I) THE PERITONEAL CATHETER WAS CUT NEAR FROM THE OUTSIDE CONNECTOR OF THE VALVE; II) THE PERITONEAL CATHETER FELL DOWN INTO THE PERITONEUM. A REVISION OF THE PERITONEAL CATHETER WAS DONE IN 2003 AND THE CUT-AND-FELL-DOWN CATHETER HARDLY REMOVED.
Remedial action
- Other