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

Catalog Number 828804PL

Device Problem Increase in Pressure (1491)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the certas valve was close to 22cm high pressure of water when performing a bench test during procedure before implantation.The procedure was completed with a replacement product and the event led to 5 minutes surgical delay.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The certas valve was returned for evaluation: device history record (dhr) - lot 4131217, conformed to the specifications when released to stock on the 4th november 2019.Failure analysis - the valve was visually inspected, no defects were noted.The valve passed the test for programming, occlusion, leaks, 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 to an excessive flow rate (>0.75 ml/min) during the flushing procedure activates the siphon guard and creates the impression that the valve is distally occluded.In reality the flow is being diverted to the high resistance secondary pathway, this will slow the rate at which csf is shunted from the brain.It would probably explain the problem encountered by the customer.

• 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: 10497843
• MDR Text Key: 206527690
• Report Number: 3013886523-2020-00089
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 828804PL
• Device Lot Number: 4131217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1