MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM VENTRICULAR CATH; STANDARD CATHETERS

Catalog Number	823041
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
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
This is 2 of 3 reports linked to mfg report numbers: 3013886523-2025-00273 , 3013886523-2025-00274.A physician reported that a hakim valve (id 823164), a hakim ventricular catheter (id 823041), and a bactiseal peritoneal catheter (id 823074) were implanted via a ventriculoperitoneal (vp) shunt on an unknown date and in an unknown setting.The devices were removed due to suspected obstruction on an unknown date.The patient¿s condition improved after explantation, so the devices were not replaced.According to information provided, it is unknown if patient had any signs and symptoms due to suspicion of obstruction.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The hakim ventricular catheter (id 823041) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects noted.Biological debris were noted on the catheter.The catheter was leak tested; no leak was observed.The catheter was irrigated; no occlusions was noted.The complaint was not confirmed.Root cause analysis - 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 not be clearly determined as only 78mm catheter of the 140mm were returned.It could be due to biological debris occluding the catheter or due to a kink in the catheter.

• Brand Name: HAKIM VENTRICULAR CATH
• Common Device Name: STANDARD CATHETERS
• 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: 23322777
• Report Number: 3013886523-2025-00272
• Device Sequence Number: 10637954
• Product Code: JXG
• UDI-Device Identifier: 10381780518815
• UDI-Public: 10381780518815
• Combination Product (Y/N): Y
• PMA/510(K) Number: K944222
• 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): 12/11/2025

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: 823041
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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: BACTISEAL PERITHONEAL CATHETER (ID 823074); HAKIM VALVE (ID 823164)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown