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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. RICKHAM RESERVOIR CNS SHUNT

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CODMAN & SHURTLEFF, INC. RICKHAM RESERVOIR CNS SHUNT Back to Search Results
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.
 
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Brand NameRICKHAM RESERVOIR
Type of DeviceCNS SHUNT
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8128097
MDR Text Key129152430
Report Number1226348-2018-10838
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number82-1625
Device Lot Number131335
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/04/2018 Patient Sequence Number: 1
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