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

Catalog Number	828810PL
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
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 a certas valve (id 828810pl) was implanted on (b)(6) 2023.The valve setting was successfully changed from 1 to 2 on (b)(6) 2024.On (b)(6) , 2024, after checking again, the valve was set to 1.The valve was stuck at level 1 and could not be adjusted, despite numerous attempts by various programmers.The patient did not presented signs and symptoms due to valve failure.Therefore, the valve was removed and replaced on (b)(6) 2024.On (b)(6) 2024, the patient was discharged and in a stable condition.
Additional Manufacturer Narrative
The certas valve (id 828810pl) was returned for evaluation.Device history record (dhr) ¿ product code 82-8810pl with lot 5949435, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; no defects noted.The valve passed the test for programming, leaks and occlusion.The valve failed the test for reflux and pressure.The valve was dismantled and was examined under microscope at appropriate magnification; biological debris was noted on the flat spring of cam ball arm assembly and the rotation construct, and the ruby ball.Root cause analysis - no root cause could be determined for the issue reported by the customer as the technician could not confirm any programing issues with the valve at the time of investigation.The possible root causes for the issue reported by the customer could be due to the pressure issue noted during the investigation.The root cause for the reflux and pressure issues noted during the investigation were due to biological debris interfering with the valve mechanism.
Additional Manufacturer Narrative
Updated fields: a2, a3a, a4, g3, g6, h2, h3, h10, h11.Additional information received: - where did this event occur? hospital.- the device(s) may have caused or contributed to: minor injury to the patient or health care provider (indicates voluntary report).- was there a problem with the device (such as a defect, malfunction, break, etc)? yes.- was someone directly "operating" the device at the time of the event? yes.- were there other devices being used on the patient at the time of the event that may have caused or contributed to the event? none.- were there other therapies being used on the patient at the time of the event that may have caused or contributed to the event? no other therapies.- what was the original intended procedure? distal ventriculoperitoneal shunt revision.- patient's age at time of event: 3 years.- patient's sex: male.- patient's weight: 11 kilograms.- did the patient have any preexisting characteristics that may have contributed to the event? not known - approximate age of device: 11 months.
Event or Problem Description
N/a.

• 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 08540 ; 6099362319
• MDR Report Key: 19391942
• Report Number: 3013886523-2024-00151
• Device Sequence Number: 7753683
• Product Code: JXG
• UDI-Device Identifier: 10381780529316
• UDI-Public: (01)10381780529316(17)261031(10)5949435
• 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: 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,Followup
• Report Date (Section B): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828810PL
• Device Lot Number: 5949435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 07/30/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/19/2024; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 MO
• Patient Sex: Male
• Patient Weight: 11 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White