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

Model Number	828805PL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A facility reported a certas valve was implanted via v-p shunt on (b)(6) 2022 with unknown setting.On (b)(6) 2023 the set pressure was changed from setting 4 to 3; however, the ventricles did not shrink.Since the valve's peritoneal catheter was clogged, the shunt system was removed and replaced on (b)(6) 2023,.
Additional Manufacturer Narrative
The certas valve (id 828805 ) was returned for evaluation.Failure analysis- the position of the cam when valve was received was at setting 3.The valve was visually inspected; a tear or cut was noted in the needle chamber.The catheters were irrigated; a tear or cut was noted in the catheter.The valve was hydrated.After hydration, the setting stay at 3, any change was noted.The valve was leak tested; the leak tested passed, only leaked from the needle hole in the needle chamber.The valve passed the test for programming, flushed, 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.However, 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, at the time of investigation no function issues were noted.The root cause for the ¿tear/cut noted in the catheter ¿ is due to a sharp or pointed object coming into contact with the catheter.
Event or Problem Description
N/a.

• 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 ; 6099362319
• MDR Report Key: 16242065
• Report Number: 3013886523-2023-00016
• Device Sequence Number: 15066220
• Product Code: JXG
• UDI-Device Identifier: 10381780521211
• UDI-Public: 10381780521211
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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
• Operator of Device: Health Professional
• Device Model Number: 828805PL
• Device Catalogue Number: 828805PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 05/04/2023
• 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
• Patient Sex: Male