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

Model Number	82-8811PL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas valve (id 828811pl) was implanted on (b)(6) 2022 with a set pressure of 7.On (b)(6) 2022, valve was found to be incorrectly set to 3.The patient had symptoms of over-drainage.A 3t mri was performed on (b)(6) 2022 prior on finding the incorrect setting.The valve was removed on (b)(6) 2022.
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.
Additional Manufacturer Narrative
The certas valve (id 828811pl) was returned for evaluation.Dhr - lot 4499922, conformed to the specifications when released to stock failure analysis - the position of the cam when valve was received was at setting 7.The valve was visually inspected; no defect was noted.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.

• Brand Name: CRTS SM IL VLV W CATH ACC
• 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: 16064203
• Report Number: 3013886523-2022-00586
• Device Sequence Number: 20509567
• Product Code: JXG
• UDI-Device Identifier: 10886704081906
• UDI-Public: (01)10886704081906(17)250131(10)4499922
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• 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,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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 Expiration Date: 01/31/2025
• Device Model Number: 82-8811PL
• Device Catalogue Number: 828811PL
• Device Lot Number: 4499932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2020
• 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