MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE VALVE 120CM; CERTAS PLUS W/ BACTISEAL

Model Number	828803PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2022
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 facility reported a certas valve (id 828803pl) failed while implanted and needed to be replaced.No additional information was provided after several attempts.
Additional Manufacturer Narrative
The certas valve (id (b)(6)) was returned for evaluation.Device history record (dhr) - the product code 82-8803pl with lot 6232142, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; a needle hole in the needle chamber was noted.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 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 causes for the issue reported by the customer could have been due to, biological debris and protein build up interfering with the valve mechanism, but at the time of investigation no functional issues were noted with the valve.Additional information received: implanted (b)(6), 2022 and explanted (b)(6), 2022 the problem was after implantation, patient readmitted with symptoms.

• Brand Name: CERTAS PLUS INLINE VALVE 120CM
• Common Device Name: CERTAS PLUS W/ BACTISEAL
• 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: 15741420
• Report Number: 3013886523-2022-00517
• Device Sequence Number: 11492442
• Product Code: JXG
• UDI-Device Identifier: 10381780521136
• UDI-Public: (01)10381780521136(17)230228(10)6232142
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/05/2022

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 Expiration Date: 02/28/2023
• Device Model Number: 828803PL
• Device Catalogue Number: 828803PL
• Device Lot Number: 6232142
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/06/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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