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

Model Number	82-8804PL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	03/03/2022
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 physician reported a certas plus valve was implanted on (b)(6) 2021 with setting 4.The patient presented with increase in ventricle size.The physician tried to reprogram the valve to 3 with a etk and the valve stayed at 4.After many attempts including with the basic tool kit and low profile tool, the setting remained at 4.The large magnet couldn¿t move the setting off of 4.X-ray confirmed setting is stuck at 4.The valve was explanted and replaced on (b)(6), 2022.
Additional Manufacturer Narrative
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; needle hole was noted in the needle chamber.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, 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 biological debris and protein build up interfering with the valve mechanism, but at the time of investigation no programing issues were noted.

• 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: 13791619
• Report Number: 3013886523-2022-00093
• Device Sequence Number: 13904693
• Product Code: JXG
• UDI-Device Identifier: 10886704079040
• UDI-Public: 10886704079040
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 82-8804PL
• 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): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/19/2022
• 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: Unknown