inforMED
MalfunctionDPW

NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1XL

Received Sep 9, 2005

Report 2023988-2005-00037 · MDR key 671250

Device

Generic name

Neurosensor

Model number

*

Catalog number

NS-P

Lot number

W050708

Product problems

  • No Display/Image
  • Use of Device Problem
  • Malposition of Device

Patient

Not reported

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

A CBF (CEREBRAL BLOOD FLOW) MONITOR AND EVD WERE PLACED. THE SURGEON DID NOT UTILIZED A LICOX. THE CBF AND ICP WAVEFORM NEVER MATERIALIZED AT EITHER 20MM OR 25MM DEPTHS. THE NEUROSURGEON FELT IT MAY HAVE BEEN ATTRIBUTED TO THE PT'S SKULL PATHOLOGY. THE PT'S HEAD CT WAS VIEWED AND THE SKULL APPEARED VERY THICK, IT WAS ALSO OBSERVED THAT THE NEUROSURGEON PLACED THE CATHETERS MORE ANTERIOR THAN WHAT THE DIRECTIONS FOR USE (DFU) RECOMMENDS. GIVEN THE THICK BONE AND UNK DEPTH OF THE SUBARACHNOID SPACE, THE CATHETER MAY BE LOCATED IN THE PARENCHYMA. LOW CBF AND ICP VALUES WERE OBSERVED, HOWEVER, THE WAVEFORM WAS A FLAT LINE.