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

Model Number	828810PL
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2023
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
3 of 5 reports (different patients, different certas valves, same facility).Other mfg report numbers: 3013886523-2023-00147.3013886523-2023-00148.3013886523-2023-00150.3013886523-2023-00151.A facility reported a certas plus (id 828810pl) was implanted on (b)(6) 2023.The valve has no flow when checked with manometer on back table, therefore, it was removed on (b)(6) 2023 and the issue was resolved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Certas valve (id 828810pl) was returned for evaluation.Device history record (dhr)- the product code 82-8810pl with lot 6604068 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 and no defect was noted.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux, and pressure.The valve functions.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 was probably due to after steam sterilization the ruby ball sticks to the ruby seat¿ potential effect(s) of failure include ¿'excessive pressure required to flush the valve pre-procedure ("valve popping).

• Brand Name: CRTS SM IL VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA
• 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: 16942085
• Report Number: 3013886523-2023-00149
• Device Sequence Number: 12515830
• Product Code: JXG
• UDI-Device Identifier: 10381780529316
• UDI-Public: (01)10381780529316(17)270831(10)6604068
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• 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): 07/19/2023

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: 828810PL
• Device Catalogue Number: 828810PL
• Device Lot Number: 6604068
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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