MAUDE Adverse Event Report: Integra LifeSciences Switzerland SAR CRTS SM IL SG UTZ BAC CATH ACC; Bactiseal

Catalog Number	828817PL
Medical Device Problem Codes	Disconnection (1171); Unintended System Motion (1430); Expulsion (2933)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a certas valve (id: 828817pl) changed settings: on (b)(6) 2025, it was programmed to 2.On (b)(6) 2026, the patient underwent an x-ray and presented to the emergency room (er) with a suspected shunt malfunction.A computed tomography (ct) scan performed the same day revealed a shunt disconnection.The right frontal approach ventricular catheter tip had migrated to the suprasellar cistern in the vicinity of the optic chiasm, and the proximal aspect of the ventricular catheter appeared detached from the shunt valve.The ventricular caliber had slightly increased, particularly in the temporal horns, which may reflect developing hydrocephalus.Also on (b)(6) 2026, the patient underwent magnetic resonance imaging (mri).Following the mri, the patient was taken to the operating room (or) to reattach the catheter to the valve.In the operating room, the medtronic strata programming tool was erroneously used to reset the shunt to 2.0 (a medtronic setting, not a certas plus setting).However, an x-ray taken on (b)(6) 2026, revealed that the certas valve was set to 4.The patient was exposed to a 1.5t ge magnet.
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.

• Brand Name: CRTS SM IL SG UTZ BAC CATH ACC
• Common Device Name: 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 08540 ; +1(609)936-2319
• MDR Report Key: 50130372
• Report Number: 3013886523-2026-00188
• Device Sequence Number: 12171656
• Product Code: JXG
• UDI-Device Identifier: 10381780535829
• UDI-Public: (01)10381780535829(17)260531(10)7564645
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 828817PL
• Device Lot Number: 7564645
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 123 LB
• Patient Race: White