MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BACTISEAL CATHETER KIT

Catalog Number	823072
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 2 reports linked to mfg report number: 3013886523-2026-00137.A facility reported a hakim valve (id: 823832) and a bactiseal catheter (id: 823072) were implanted on (b)(6) 2026.Three days after, the patient developed pyrexia accompanied by leukocytosis, raising concerns for intracranial infection.Therefore, the shunt was removed on (b)(6) 2026.The samples were sent for microbiological culture to identify the causative pathogens.Currently, the patient is receiving antimicrobial therapy, with definitive surgical intervention planned once the infection is controlled or as clinically indicated.It is not known if the valve and catheter will be replaced.
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
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 bactiseal catheter (id 823072) was returned for evaluation: device history record (dhr) - the product code 823072 with lot 7627224, conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected, no defects noted.The catheter was irrigated, no occlusions noted.The catheter was leak tested; no leaks were noted.The decontamination method used on the device, eto, is not the recommended one for this product, but it didn't have an impact on the product or investigation performed.Root cause analysis - no root cause could be identified, as the investigation did not reveal any catheter related defect or abnormality, and the technician was unable to confirm any issue with the catheter at the time of evaluation.A potential root cause for the infection reported by the customer may be related to patient-specific factors and/or the clinical environment in which the catheter was used, rather than to the device itself.

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Common Device Name: BACTISEAL
• 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 ; +1(609)936-2319
• MDR Report Key: 25485463
• Report Number: 3013886523-2026-00138
• Device Sequence Number: 9930458
• Product Code: JXG
• UDI-Device Identifier: 10381780536987
• UDI-Public: (01)10381780536987(11)251209(17)261130(10)7627224
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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 Catalogue Number: 823072
• Device Lot Number: 7627224
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: Asian