MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Catalog Number	828814PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas valve (id 828814pl) was explanted as it was not functioning properly.No additional information has been provided after several attempts.
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
N/a.
Additional Manufacturer Narrative
Certas valve (id 828814pl) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected, no defects were noted.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux and siphon guard.The valve failed the test for pressure.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification, biological debris was found on the on the seat on the ruby ball and in the housing.Root cause analysis - the root cause for the pressure issue noted during the investigation is due to biological debris found on the seat on the ruby ball and in the housing.

• Brand Name: CRTS SM IL SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA 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: 18232104
• Report Number: 3013886523-2023-00419
• Device Sequence Number: 6936992
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: 10381780529378
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/18/2024

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 Catalogue Number: 828814PL
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/18/2024
• 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
• Patient Sex: Unknown