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 Problems Break (1069); Excess Flow or Over-Infusion (1311); Kinked (1339); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 12/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

On (b)(6) 2016, the l-p shunt surgery was performed and the device was implanted to the patient who was suffering from sah at ilium side.During the surgery, it was noted the catheter at ventral side was kinked, so the surgeon resolved it.The device was kept using.On (b)(6) 2016, it was noted the over drainage and deformation on the valve, so the revision was performed and the device was replaced with another device (product code was unknown).The patient¿s condition is stable.After the revision, when checking the removed device, it was found the valve was broken from the siphon guard and it barely connected to a part of silicon.The surgeon commented that he didn¿t damage the valve though he took the valve off with a pean forceps.

Manufacturer Narrative

Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The valve was visually inspected: the silicone housing is cut/torn.The position of the cam when valve was received was at setting 2.The valve was hydrated for 24 hours.The valve was tested for programming.The valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was not leak tested, due to the damaged silicone housing.The valve was not reflux tested due to the damaged silicone housing.The siphon guard was not tested due to the damaged silicone housing.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records was not possible as the lot number was unknown.The root cause for the over drainage is probably due to the damaged silicone housing, this however could not be determined.The root cause to the tear/cut in the silicone housing is probably being due to the user, this however could not be determined.As noted in the ifu silicone has a low tear / cut resistance.Per hhe, it has been 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.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6236536
• MDR Text Key: 64275808
• Report Number: 1226348-2017-10026
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention