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	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported: "the patient had initial procedure insertion of ventriculoperitoneal (vp) shunt on (b)(6) 2025.The product was codman bactiseal.The patient then had a procedure on (b)(6) 2025 for craniotomy and blockage of shunt indicated by shunt dysfunction.Patient then had a follow-up procedure on (b)(6) 2025 for removal of the vp shunt.Valve showed discoloration of the distal component.Shunt was removed from the patient, with plan for insertion of a new shunt at a later date.".
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, d9, g3, g6, h2, h3, h4, h6, h11.The codman bactiseal catheter (id 823072) was not returned for evaluation as the product is not available for return as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.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
• 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: 24129452
• Report Number: 3013886523-2026-00006
• Device Sequence Number: 10388015
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: (01)10381780515616(17)240229(10)7028039
• 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): 02/20/2026

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 823072
• Device Lot Number: 7028039
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2023
• 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