MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTSÂ SMÂ ILÂ VLVÂ WÂ CATHÂ ACC; INTERNAL CSF DRAINAGE

Catalog Number	828811PL
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
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
This is 1 of 2 reports linked to mfg report numbers: 3013886523-2025-00279.A facility reported a certas valve was implanted on (b)(6) 2019.The valve became unprogrammable and had a red spot floating on one side.As of (b)(6) 2025, the valve was set at 5, but it has been observed to change settings on its own.The valve was removed.A bactiseal catheter (id: (b)(6)) was implanted on (b)(6) 2020.The catheter was revised and removed.
Additional Manufacturer Narrative
Updated fields: d1, d2a, d4, d6a, d9, g3, g6, h2, h3, h4, h11.The certas valve (id 828811pl ) was returned for evaluation.Device history review: the product code 82-8811pl with lot 3448842 conform to specifications when released to stock failure analysis: the position of the cam when valve was received was at setting 4.The valve was visually inspected; ruby ball was dislodged from the seat.Tears observed on the needle chamber.The valve passed the test for occlusion and reflux.The valve failed the test for programming, leak and pressure.A leaked from the needle chamber.The valve was dismantled and observed under microscope: red ball was moving in the dome and the ruby seat was missing.Absence of glue was noticed in the ball seat area.Bump marks were observed on the casing.Root cause analysis: the root cause for the programming issue is due to rotation construction being stuck in up position.The root cause for the rotation construction being stuck in up position was due to the valve receiving a hard knock.The root cause for the leak issue during investigation is probably due to human misuse, as mentioned in the ifu: silicone has a low cut and tear resistance.The certas valve are 100% leak tested before release so the valve cannot have been released with this needle hole.The root cause for pressure issue noted during investigation is due to ball seat missing and ball dislodged.The root cause for the ruby ball dislodged and missing ball seat is probably due to the ball seat have not been sealed with glue, valve received a hard knock and the ball seat could have been extracted from the needle guard chamber as there is a cut at this area.There are ruby debris inside the valve proving that ruby ball was initially present.
Event or Problem Description
N/a.

• Brand Name: CRTSÂ SMÂ ILÂ VLVÂ WÂ CATHÂ ACC
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 23266826
• Report Number: 3013886523-2025-00278
• Device Sequence Number: 15991156
• Product Code: JXG
• UDI-Device Identifier: 10886704081906
• UDI-Public: (01)10886704081906(17)231231(10)3448842
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 01/07/2026

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: 12/31/2023
• Device Catalogue Number: 828811PL
• Device Lot Number: 3448842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 23CM EVD CATH W/ BACTISEAL ID NS0343
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown