MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL CATHETER KIT

Catalog Number	823072
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
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 7 reports linked to mfg report numbers: 3013886523-2025-00174.3013886523-2025-00176.3013886523-2025-00177.3013886523-2025-00178.3013886523-2025-00179.3013886523-2025-00180.A physician reported that patients implanted with the bactiseal catheter (catalog #823072) developed late-onset ventriculitis.This condition was observed in seven patients between (b)(6) 2024 and (b)(6) 2025.The ventriculitis manifested approximately one-month post-implantation.In all reported cases, the inflammation subsided within three months without the need for additional treatment.The catheters remained implanted in the patient.One of the seven cases involved bleeding.No signs of inflammation were observed around the abdomen or on the skin in any of the cases.The affected patients included individuals diagnosed with both secondary normal pressure hydrocephalus (snph) and idiopathic normal pressure hydrocephalus (inph).All patients reportedly recovered, and no further clinical details were made available by the reporting hospital.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The bactiseal catheter kit (id (b)(4)) was not returned for evaluation (product remains implanted) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.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.
Event or Problem Description
N/a.

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Common Device Name: BACTISEAL CATHETER KIT
• 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: 22520706
• Report Number: 3013886523-2025-00175
• Device Sequence Number: 15591247
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: 10381780515616
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/12/2025

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 Catalogue Number: 823072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown