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

Catalog Number	828804PL
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	08/23/2023
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 patient was experiencing enlarged ventricles with certas valve setting 1.Medical staff tapped the reservoir and they were getting pressure and flow.They revised the shunt and determined during that procedure that the distal catheter was flowing fine.The certas valve was implanted on (b)(6), 2023 and explanted/replaced on (b)(6), 2023.
Additional Manufacturer Narrative
The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr)- the product code 82-8804pl with lot 7136187, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected, a cut in the chamber was noted.The valve was hydrated.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve was leak tested and failed due to the the leaked from the cut in the needle chamber.Root cause analysis- no root cause could be determined as the technician could not confirm any occlusion issue 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, at the time of investigation no function issues were noted.The root cause for the cut noted in the needle chamber, is due a sharp or pointed object coming into contact with the valve in view of the cut marks on siphon guard.As noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.
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: 17744024
• Report Number: 3013886523-2023-00316
• Device Sequence Number: 4185046
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)280331(10)7136187
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Catalogue Number: 828804PL
• Device Lot Number: 7136187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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