MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PERITON CATH,120CM; STANDARD CATHETERS

Catalog Number	823045
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a certas valve (id 828804) and a peritoneal catheter (id 823045) were implanted via lumbar peritoneal (lp) shunt on unknown date with setting 3.After developing intraventricular hemorrhage, suspicion of shunt dysfunction was observed.A magnetic resonance imaging (mri) confirmed that the patient had developed ventricular dilatation.The setting was changed to 1: it was possible to flush the device by pumping.The patient was doing well soon after the alteration of the setting, but the patient's condition worsened within a week after that.Therefore, the catheter and the valve were removed and replaced 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 small part of the distal catheter was received.It was not possible to perform any tests and evaluate if the catheter was occluded because of the small size of the returned part.The complaint was unconfirmed.Root cause analysis -the ¿obstruction¿ issue reported by the customer could be due to biological debris occluding the catheter or a kink in the catheter.However, it was not possible to determine the root cause of the issue as the returned piece of catheter was too small to perform any relevant tests.
Event or Problem Description
N/a.

• Brand Name: HAKIM PERITON CATH,120CM
• Common Device Name: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23617423
• Report Number: 3013886523-2025-00308
• Device Sequence Number: 13271291
• 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 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): 01/08/2026

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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/08/2026
• 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: 828804 CERTAS VALVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown