MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2025
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 physician reported a bactiseal ventricular catheter (id 823073) was implanted due to communicating and acquired hydrocephalus via ventriculoperitoneal (vp) shunt on an unspecified date with an unknown setting.It was used with certas valve (id 828824).A shunt dysfunction was suspected due to cerebrospinal fluid (csf) flow could not be confirmed.Therefore, the valve was removed and replaced on (b)(6) 2025.Based on the additional information, it is unknown if the patient experienced any signs ang symptoms due to valve failure.The patient condition is unknown.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.Failure analysis - the catheter was visually inspected, no defects noted.The catheter passed the tests for occlusion and leaks.The complaint was unconfirmed.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.The possible root cause for the issue reported by the customer could be due to a kink in the catheter or an issue with the valve.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• Common Device Name: BACTISEAL VENTRICULAR CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22866233
• Report Number: 3013886523-2025-00212
• Device Sequence Number: 9338713
• Product Code: JXG
• UDI-Device Identifier: 10381780536994
• UDI-Public: 10381780536994
• Combination Product (Y/N): N
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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 Catalogue Number: 823073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CERTAS VALVE (ID 828824).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown