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

Catalog Number	828804PL
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported: "surgeon connected certas plus in-line with medtronic csf reservoir.Upon connecting the system with ventricular and peritoneal catheters, the surgeon did not experience flow.The certas plus was set to setting 4.Multiple attempts were made to verify flow, but none of them worked including using the occlude-pump-release technique and injecting liquid into the certas plus reservoir while the shunt inlet was occluded.Eventually a new certas plus valve was used and it did flow as expected.Both times the certas plus was set to setting 4.The valve issue was detected during implantation procedure, and the event led to approximately 5 minutes surgical delay.Surgeon stated that he was not sure that issue was caused by the certas plus shunt as this was a relatively complex shunt case.The certas plus valve was used with: ventricular catheter (medtronic 44104), csf reservoir (medtronic 44104), and peritoneal catheter from medtronic.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The certas valve (id 828804pl) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; the needle guard was raised.The valve was flushed, the valve failed the test.The needle guard was dismantled; the needle guard was inspected; glue traces were found on the silicone base and the needle guard.Root cause analysis - the root cause for the issue reported by the customer and for the raised needle guard was due to improper handling.As noted in the instruction for use (ifu), "do not fold or bent the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway.".

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ SG
• 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 08540 ; 6099362319
• MDR Report Key: 20274618
• Report Number: 3013886523-2024-00293
• Device Sequence Number: 3469448
• Product Code: JXG
• UDI-Device Identifier: 10381780521013
• UDI-Public: 10381780521013
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828804PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CSF RESERVOIR (MEDTRONIC 44104).; PERITONEAL CATHETER - MEDTRONIC.; VENTRICULAR CATHETER (MEDTRONIC 44104).
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White