MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM PERITON CATH,120CM; INTERNAL CSF DRAINAGE

Catalog Number	823045
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician reported a peritoneal catheter (id 823045) was implanted due to unknown reason on (b)(6) 2023 with unknown setting.On (b)(6) 2025, the patient¿s condition worsened; however, the signs and symptoms experienced were not specified.Due to suspicion of obstruction, the catheter was removed on (b)(6) 2025.
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, h6, h11.The certas valve (id 828804) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated; no occlusions were noted.The catheter was leak tested; no leaks were noted.Root cause analysis - the issue reported by the customer could not be confirmed.The issue reported by the customer could be due to biological debris and protein build up interfering with the device.A possible root cause could be that the catheter was susceptible to kinking, which could lead to an occlusion, or the reported complaint could be due to loosen ligature or increased strain on the catheter due to insufficient length.
Event or Problem Description
N/a.

• Brand Name: HAKIM PERITON CATH,120CM
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 24278013
• Report Number: 3013886523-2026-00020
• Device Sequence Number: 8253844
• Product Code: JXG
• UDI-Device Identifier: 10381780518839
• UDI-Public: 10381780518839
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 02/27/2026

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: 823045
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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 INLIN VLV ONLY W/SPHNGD (ID 828804); LONG HAKIM VENTRICULAR CATHETER (ID NS9001)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown