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 Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) 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 by the ous affiliate that a certas inline valve and catheters were blocked, and the devices were removed.There are no reported patient symptoms associated with this event.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

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

Manufacturer Narrative

The valve was returned for evaluation.The position of the cam when valve was received was at setting 3.The valve was visually inspected; the silicone housing was torn/cut in the needle chamber.The valve was tested for programming and passed.The valve was flushed and leaked from the tear/cut in the needle chamber, no occlusion was noted.The valve was leak tested and leaked from the tear/cut in the needle chamber.The catheter was irrigated; no occlusion was noted.Reflux testing found no issues.The siphon guard was tested and passed.The valve could not be pressure tested due to the damage to the needle chamber.The reported issue of blockage could not be confirmed, no occlusions were observed.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.Previous investigation has determined that silicone housing tears are not design related.In order for the housing tear to occur the silicone has to be compromised through a nick or tear.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 complaints.At present, we consider this complaint to be closed.

• 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: 7393002
• MDR Text Key: 104201472
• Report Number: 1226348-2018-10259
• 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,health professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-8804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention