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

Catalog Number 82-8804

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that a certas with siphonguard valve had to be revised and it was noted that the silicone housing was torn.The complaint device had been inserted as a vp system.During the revision, it was noted that the outer silicon coating over the siphonguard, while still attached to the valve, had ruptured.The surgeon revised the valve, 828800 (certas plus without siphonguard).No abnormal issues were reported post revision of the valve.

Manufacturer Narrative

Udi: (b)(4).The device was returned for evaluation.The position of the cam when valve was received was at setting 2.The valve was visually inspected: the silicone housing around the siphon guard was cut/torn.A review of manufacturing records found the valve met specification when released to stock.The root cause for the tear/cut in the silicone housing is probably due to the user.As noted in the ifu, silicone has a low tear / cut resistance.Previous investigation of this issue has 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.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

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

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7469305
• MDR Text Key: 106774585
• Report Number: 1226348-2018-10313
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K112156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 82-8804
• Device Lot Number: 117783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention