MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 11/21/2020

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 functional issue with a shunt valve.A certas plus valve was implanted in a patient via ventricular peritoneal shunt on (b)(6) 2018 with an unknown initial setting.On an unknown date a valve obstruction was suspected, and it was found that flow could not be confirmed by contrast agent.No clinical symptoms were provided.The patient was taken to the operating room for replacement to a new valve on (b)(6) 2020.The patient recovered from surgery and was discharged home.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; needle holes in the needle chamber was noted.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, ref;ux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due biological debris and protein buildup interfering with the valve mechanism, at the time of the investigation no occlusions/programming issues were noted.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11042031
• MDR Text Key: 222646788
• Report Number: 3013886523-2020-00257
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR