MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN CERTAS; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 828803PL

Device Problems Flushing Problem (1252); Hole In Material (1293); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/14/2016

Event Type  malfunction  

Event Description

The surgeon was placing the shunt in the patient, when testing shunt the surgeon stated that the shunt didn't flush and there was a hole in it.A shunt valve was opened for the procedure and it malfunctioned when it was first implanted.It was removed and replaced.

• Brand Name: CODMAN CERTAS
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6438939
• MDR Text Key: 71019773
• Report Number: 6438939
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 828803PL
• Device Lot Number: CVLBPC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1