MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLIN VLV SPHN/UNIT CAT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8806

Device Problem Obstruction of Flow (2423)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that shunt occlusion failure occurred after implantation, the patient was symptomatic and a revision was performed.The valve was implanted to the patient via vp-shunt secondary to communicating hydrocephalus, date of implant and initial setting are unknown.The revision surgery was performed on (b)(6) 2018 owing to bad health.Csf protein: unknown.No further information was provided by the hospital.The product will not be returned to your site.

Manufacturer Narrative

The device was returned for evaluation.The position of the cam when valve was received was at setting 4.The valve was visually inspected: it was noted that the silicone was torn/cut around the siphon guard and the needle chamber as well as biological debris in the siphon guard.The valve was tested for programming and passed the test.The valve was flushed and leaked from the tear/cut in the needle chamber.The valve was leak and leaked from the tear cut in the silicone housing in the needle chamber.The valve could not be reflux tested due to the damage silicone housing.The siphon guard was tested and failed due to blockage of biological debris.The valve was then pressure tested and failed the test.A review of manufacturing records could not be performed, as no lot number information was provided.The root cause for the tear/cut in the silicone housing is likely due to the user.As noted in the ifu silicone has a low tear / cut resistance.Tears in silicone housing have been previously investigated.It was concluded that silicone housing tears are not design related, in order for the housing tear to occur the user has to compromise the silicone through a nick or tear in order for the event to occur.Validation testing demonstrates a robust design.Testing has shown that if the silicone housing has been compromised, a housing tear is likely to occur.The root cause for the blocked siphon guard was due to biological debris.Trends will be monitored for this and similar issues.At present we consider this complaint to be closed.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29 case postale; le locle ; SZ
• MDR Report Key: 7554270
• MDR Text Key: 109568013
• Report Number: 1226348-2018-10373
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-8806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1