MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8804PL

Device Problem Break (1069)

Patient Problem Swelling (2091)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient visited clinic on (b)(6) observed swelling around valve site.Patient admitted for surgery on (b)(6) and operated to revise shunt.Observed broken siphonguard.And replaced valve.Replaced valve with new certas plus.No delays.

Manufacturer Narrative

Upon completion of the investigation it was noted that the position of the cam when valve was received was at setting 8.The valve was visually inspected: confirms the broken silicone housing and the siphon guard no longer attached to the valve, clamp marks were noted on the hard plastic of the siphon guard.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 could not be leak tested due to the damage silicone housing.The valve could not be reflux tested due to the damage silicone housing.The valve was dried.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.The root cause for the damaged silicone housing is probably due to user¿s error when using clamps/forceps, 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 PLUS INLINE WITH SIPHONGUARD VALVE ONLY
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5963882
• MDR Text Key: 55164888
• Report Number: 1226348-2016-10677
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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: 09/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8804PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2016
• 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