MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number 828804PL

Device Problem No Device Output (1435)

Patient Problem Injury (2348)

Event Date 02/05/2021

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.

Event Description

A facility reported that a patient was implanted with a certas valve w/sg on an unknown date with a setting of 6 for a vp shunt.Initially, everything was fine.A decision at some point was made to change the setting to 7 and that was also fine.At some point another decision was made to dial the valve back to 6 and that is when the issue occurred.No matter what programmer was tried, the valve would not adjust.The decision was made to replace the valve.The valve is being sent back for evaluation.

Manufacturer Narrative

The certas valve was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 5.The valve was visually inspected; no defects were noted.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, 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 programing issues were noted.

Event Description

N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• 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: 11389501
• MDR Text Key: 234250499
• Report Number: 3013886523-2021-00092
• 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: 828804PL
• 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