It was reported from (b)(6), that a patient had an implantation of an intracerebral rickham ventriculostomy (icv) set (codman shurtleff generic icv device).
The patient¿s developed swelling around the catheter site, reported as extravasation.
The reporter assessed the event of catheter site extravasation as related to the icv device.
An event of catheter site extravasation of csf after infusion of a small amount of study drug in a study subject.
The catheter placement is suspected to be related to the catheter site extravasation and not related to the study drug.
The monitoring of the rickham device by nuclear magnetic resonance imaging (mri) showed a normal position of the catheter.
No other etiological factors were suspected.
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