MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL BARIUM STRIPED CATH

Catalog Number	NS0340
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a certas valve (id 828814) and bactiseal catheter (id ns0340) were implanted due to unknown reason via ventriculoperitoneal (v-p) shunt on unknown date with unknown setting.Cerebrospinal fluid is not flowing well therefore the device was explanted.The patient didnt experienced any signs and symptoms of obstruction.
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.
Additional Manufacturer Narrative
Updated fields: d4, d8, d9, g6, h1, h2, h3, h6, h11.The bactiseal catheter (ns0340) was returned for evaluation.Failure analysis - the catheter was visually inspected, no defects noted.The catheter was irrigated, no occlusions noted.Root cause - 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".

• Brand Name: BACTISEAL BARIUM STRIPED CATH
• 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: 24400454
• Report Number: 3013886523-2026-00034
• Device Sequence Number: 9748712
• Product Code: JXG
• UDI-Device Identifier: 10381780524076
• UDI-Public: 10381780524076
• 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): 04/10/2026

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: NS0340
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/10/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown