MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8804

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

Udi - (b)(4).The device has been returned and is awaiting evaluation.A follow-up report will be submitted upon completion.

Event Description

As reported, during implantation, a certas plus valve was observed leaking from the reservoir.It was replaced with a new valve, the procedure completed.The surgeon commented that the valve should not have been damaged during the procedure.No further information was provided by the hospital.The valve will be returned.

Manufacturer Narrative

The device was returned for evaluation.The position of the cam when the valve was received was at setting 5.The valve was visually inspected; the silicone housing was cut/torn in the needle chamber and the needle guard was raised.The root cause for the damage silicone house is probably due to a sharp or pointed object coming into contact with the silicone.As noted in the ifu silicone has a low cut/tear resistance.The root cause for the raised needle guard base, was probably due to user error, as noted in the ifu: do not fold or bend the valve during insertion.Folding or bending might cause rupture of the silicone housing, needle guard dislodgement, or occlusion of the fluid pathway.A review of manufacturing records found that the device conformed to specification when released to stock.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 8128814
• MDR Text Key: 129332370
• Report Number: 1226348-2018-10841
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 82-8804
• Device Lot Number: 196492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1