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

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.

• Brand Name: RICKHAM RESERVOIR
• Type of Device: CNS SHUNT
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 8128097
• MDR Text Key: 129152430
• Report Number: 1226348-2018-10838
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study,user facility
• 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 Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 82-1625
• Device Lot Number: 131335
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

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