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	Cerebral Ventriculomegaly (2133)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim ventricular catheter (id 823041) was implanted due to communicating hydrocephalus and secondary normal pressure hydrocephalus (snph) via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.An obstruction was suspected in the catheter.The patient experienced disorientation due to ventricular dilation, and an x-ray confirmed the obstruction of the device.Therefore, a patient undergone revision surgery.The catheter was explanted and replaced on (b)(6) 2024.No surgical delay was reported.According to information provided, it is unknown if there was a failure with the valve.It is also unknown if the valve was explanted and replaced.
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
N/a.
Additional Manufacturer Narrative
The hakim ventricular catheter (id 823041) was returned for evaluation.Failure analysis - the catheter was visually inspected: biological debris could be seen in some of the catheter holes.The catheter was flushed; flow was noted from most of the catheter holes and only a few where the flow was slow.Root cause analysis - no root cause could be determined for the failure issue reported by the customer as the technician could not confirm an occlusion with the catheter at the time of investigation.The possible root cause for the issue reported by the customer is probably due to biological debris and protein build up.Although, no real occlusion was noted during the investigation, it is possible that the debris has moved during transportation, decontamination process, but this could not be confirmed.

• Brand Name: HAKIM VENTRICULAR CATH
• Common Device Name: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18787810
• Report Number: 3013886523-2024-00044
• Device Sequence Number: 15412127
• Product Code: JXG
• UDI-Device Identifier: 10381780518815
• UDI-Public: 10381780518815
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 04/11/2024

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): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/11/2024
• 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: VALVE
• Patient Sex: Unknown