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

Catalog Number	823072
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	04/13/2026
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 catheter (id 823072) was implanted due to idiopathic normal-pressure hydrocephalus (inph) via ventriculoperitoneal (vp) shunt on (b)(6) 2024.The catheter was implanted with certas valve (id 828824) with setting 7.According to an x-ray, ventricular dilatation was observed, and on (b)(6) 2026, shunt obstruction was suspected since the ventricle did not shrink even after pressing the reservoir several times.The patient developed gait disorder, therefore, the devices were explanted and replaced on (b)(6) 2026.
Additional Manufacturer Narrative
The bactiseal catheter (id (b)(6)) was returned for evaluation.Failure analysis: the catheter was visually inspected, no defects noted.The catheter was irrigated, no occlusions noted.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 biological debris occluding the catheter or due to a kink in the catheter.According to ifu " complications of implanted shunt systems are mechanical failure, shunt pathway obstruction.".
Event or Problem Description
Na.

• 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 ; 6099362319
• MDR Report Key: 25056062
• Report Number: 3013886523-2026-00100
• Device Sequence Number: 9427742
• Product Code: JXG
• UDI-Device Identifier: 10381780536987
• UDI-Public: 10381780536987
• 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: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 823072
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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 828824; CERTAS VALVE 828824.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male