MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	11/30/2025
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
This is 2 of 2 reports linked to mfg report number: 3013886523-2025-00333.A facility reported a peritoneal catheter (id 823074) was implanted via ventriculoperitoneal (vp) shunt on (b)(6) 2025 with initial setting of 145 mmh2o.The first adjustment was performed on (b)(6) 2025 and was changed to 180 mmh2o.The patient had persistent high fever on (b)(6) 2025.A cerebrospinal fluid (csf) analysis was performed, and a bacterial infection was confirmed.Due to the infection the patient had emergency craniotomy on (b)(6) 2025 revealing intracranial infection.The patient was placed on antibiotics.Based on information provided, it is unknown if the cause infection is related to the device.No information if anything happened during the recent procedure that may have caused or contributed to infection.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The bactiseal peritoneal catheter (id 823074) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint could be linked to the patient and hospital surroundings.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• 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: 23892391
• Report Number: 3013886523-2025-00334
• Device Sequence Number: 14590730
• Product Code: JXG
• UDI-Device Identifier: 10381780537007
• UDI-Public: (01)10381780537007(11)250409(17)260331(10)7543476
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 823074
• Device Lot Number: 7543476
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BACTISEAL VENTRICULAR CATHETER (ID 823073); CERTAS VALVE (ID 828805)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male