MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CERTAS PLUS INLINE VALVE ONLY

Catalog Number 828800PL

Device Problem Infusion or Flow Problem (2964)

Patient Problem Failure of Implant (1924)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the certas plus valve was opened on the surgical back table and placed in the patient.Once the ventricular catheters were attached, they noticed that there was no distal flow.The valve was replace and proceeded to flow appropriately.

Manufacturer Narrative

The certas valve was returned for evaluation: device history record (dhr) - lot number 5101887 with no anomalies.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; the needle guard was raised.A needle hole in the needle chamber was also noted.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer "once the ventricular catheters was attached they noticed that there was not distal flow" is probably due to wrong handling.As noted in the ifu: "do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway", but at the time of the investigation no occlusion was noted.

• Brand Name: CERTAS PLUS INLINE VALVE ONLY
• Type of Device: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• MDR Report Key: 11838220
• MDR Text Key: 256732506
• Report Number: 3013886523-2021-00222
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828800PL
• Device Lot Number: 5101887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1