|
Catalog Number 82-1625 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Host-Tissue Reaction (1297)
|
Event Date 10/26/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).
Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.
A lot number has been provided.
Upon review of the manufacturing records, a follow-up report will be submitted.
|
|
Event Description
|
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.
|
|
Manufacturer Narrative
|
Udi: (b)(4).
Multiple attempts to obtain additional information were not successful.
Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.
A review of manufacturing records found the device conformed to specification when released to stock.
The cause(s) of the difficulty reported by the customer could not be determined.
If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.
Trends will be monitored for this or similar complaints.
At present, we consider this complaint to be closed.
|
|
Search Alerts/Recalls
|
|
|