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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
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 certas valve (id 828804) and a bactiseal catheter (id 823072) were implanted due to secondary normal pressure hydrocephalus (snph) via ventriculoperitoneal (vp) shunt, approximately a year ago with an unknown setting.A revision was performed by the end of (b)(6) 2026 due to shunt malfunction.Only the certas valve was explanted and replaced with catalogue #823013; the ventricular and peritoneal catheters were not replaced.Debris was observed inside the valve.Since the peritoneal catheter was not explanted, there is still a suspicion of obstruction on the catheter.The patient is currently in follow-up.Primary disease: brain tumor.
Additional Manufacturer Narrative
Updated fields: d4, d9.G3, g4, g6.H2, h3, h11.The bactiseal catheter (id 823072)) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history records (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint 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." 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
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: 24400471
• Report Number: 3013886523-2026-00030
• Device Sequence Number: 8132794
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: 10381780515616
• Combination Product (Y/N): N
• 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?: Yes
• 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: 01/30/2026
• 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): 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
• Concomitant Medical Products and Therapy/Usage Dates: CERTAS VALVE (ID 828804)
• Patient Sex: Unknown