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

Model Number	828814PL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Dizziness (2194); Balance Problems (4401)
Date of Event	04/06/2022
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 828814pl) was implanted in a (b)(6) year-old male patient on (b)(6) 2021.The patient had dizziness and imbalance after 10 to 12 weeks of implantation.The valve was explanted on (b)(6) 2022 and an "evd" was placed.The distal end of the shunt detached or broke.All the broken parts were recovered and no x-ray was required to assure no parts left in the patient because the broken valve was still attached to the distal catheter.The patient is in observation for several days and being followed by the neuro team.
Additional Manufacturer Narrative
The certas valve (id (b)(6)) was returned for evaluation.Device history record (dhr) - lot 5407266 conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a cut/tear in the silicon housing along the siphon guard and a needle hole in the needle chamber were noted.The position of the rotation construct when valve was received was setting 4.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, siphon guard and pressure.The valve functions.No root cause could be determined as the technician could not confirm any functional problem with the valve at the time of investigation.The possible root cause for the problem reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no functional issues were noted.The root cause for the cut/tear in the silicon housing along the siphon guard reported by the customer, is due to the damaged silicone housing, as noted in the ifu, silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• 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: 14160281
• Report Number: 3013886523-2022-00176
• Device Sequence Number: 2944355
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: (01)10381780529378(17)260228(10)5407266
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 02/28/2026
• Device Model Number: 828814PL
• Device Catalogue Number: 828814PL
• Device Lot Number: 5407266
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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
• Patient Age: 12 YR
• Patient Sex: Male