MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN CERTAS INLINE VLV; CERTAS PLUS

Catalog Number 828801

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 07/05/2022

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.

Event Description

A physician reported a certas valve (id 828810) was implanted via v-p shunt in 2019 with unknown setting.The ventricles size did not change, then the setting was set to 2.A ct imaging was performed and shunt failure was suspected; therefore, the valve was removed and replaced on (b)(6) 2022.

Manufacturer Narrative

The certas valve was returned for evaluation.Device history record (dhr) - no anomalies.Failure analysis - the valve was visually inspected; the needle guard was raised and holes in the needle chamber were noted.The position of the cam when valve was received was at setting 2.The valve was hydrated.The catheter was irrigated no occlusion noted.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.No root cause could be determined as the technician could not confirm any shunt failure at the time of investigation.The root cause for the raised needle guard noted during the investigation is due to wrong handling as noted in the ifu: do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism at the time of investigation no functional issues were noted with the valve.

• Brand Name: CODMAN CERTAS INLINE VLV
• Type of Device: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15102758
• MDR Text Key: 296571006
• Report Number: 3013886523-2022-00335
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704071334
• UDI-Public: (01)10886704071334(17)230131(10)179787
• Combination Product (y/n): N
• PMA/PMN Number: K182265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 828801
• Device Lot Number: 179787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1