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

Catalog Number	828807PL
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2024
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 debris (blood) was found inside the certas plus valve (id 828807pl).The valve was implanted on (b)(6) 2024 and due to a concerned of malfunction, it was explanted and replaced with a new certas shunt on (b)(6) 2024.Upon review, a debris (blood) was observed inside the valve mechanism.A physician noted that the debris may have caused the malfunction.No patient¿s signs and symptoms reported due to valve malfunction and the new shunt is working well on patient.
Additional Manufacturer Narrative
The certas valve (id 828807pl) was returned for evaluation.Device history record (dhr) ¿ the product code 82-8807pl with lot 7321571, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; the siphon guard was damaged and a cut mars were noted on the siphon guard.The valve passed the tests for programming and pressure.The flush, leak, reflux, and siphon guard tests could not be performed as the siphon guard was damaged.Root cause analysis - at the time of investigation, no function issues were noted.A possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve.The root cause for the ¿siphon guard damaged¿ is due to 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 instruction for use (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/ BACTISEAL & 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: 18788683
• Report Number: 3013886523-2024-00053
• Device Sequence Number: 8255749
• Product Code: JXG
• UDI-Device Identifier: 10381780521280
• UDI-Public: (01)10381780521280(17)241031(10)7321571
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 828807PL
• Device Lot Number: 7321571
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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 Age: 54 YR
• Patient Sex: Female