MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE SEPAR

Catalog Number 828801PL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Headache (1880); Cerebral Ventriculomeglia (2133); Injury (2348)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.(b)(4).

Event Description

A facility reported that a certas valve was implanted in a (b)(6) male patient on (b)(6) 2018.The surgeon thinks that valve was malfunctioning as a physiological response of the ventricle size was not consistent with the settings of the valve or the valve setting changes.There is also suspicion that the valve changed settings without medical intervention but cannot be substantiated as there is no xray.The patient presented with enlarged ventricles, headache, behavior, lethargy clinician believed the valve set to 3 and the valve was interrogated with both the mechanical and electronic programmer at 2 by the same np.The valve was then replaced, and surgery was completed on (b)(6) 2021.The patient was transferred to the floor and released.The patient is currently stable.

Manufacturer Narrative

The certas valve was returned for evaluation: review of the history device records was not possible as the lot number and was unknown.Failure analysis: the position of the cam when valve was received was at setting 2.The valve was visually inspected; biological debris was noted on the cam mechanism and needle holes in the needle chamber were noted.The valve was hydrated.The valve failed the test for programming and reflux.The valve passed the test for occlusion and pressure.The valve was leak tested; only leaked from the needle holes in the needle chamber.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was noted covering the rotating construct and the ruby ball.The root cause for the malfunctioning issue reported by the customer is due to biological debris and protein buildup found on the rotating construct and the ruby ball.

Event Description

N/a.

• Brand Name: CERTAS PLUS INLINE VALVE SEPAR
• Type of Device: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11389499
• MDR Text Key: 234251666
• Report Number: 3013886523-2021-00091
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828801PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR