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 Kinked (1339)

Patient Problem No Information (3190)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The valve was implanted to the patient.Doi and initial setting were unknown.It was reported that suspicion of failure on the lumbar side occurred when the shunt contrast was performed on (b)(6).The surgeon tried to resolve kinking on the lumbar side on (b)(6).The revision surgery was performed on (b)(6).The patient¿s information is unknown.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

Upon completion of the investigation it was noted that the position of the cam when valve was received was at setting 2.The valve was visually inspected; it was noted that the needle base was slight raised, as well as needle holes in the needle chamber.The valve was hydrated.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 leak tested.Leaked from the needle holes in the needle chamber.The valve was reflux tested.The valve passed the test.The siphon guard was tested.The valve passed the test.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 is unknown.No functional problem was noted with the valve.The root cause for the slightly 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.), this however could not be determined.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 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7160980
• MDR Text Key: 96334192
• Report Number: 1226348-2018-10007
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2018
• 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