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 Edema (4403)
Date of Event	06/25/2024
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
A physician reported a ventricular catheter (id 823041) and a certas valve were implanted with unknown setting due to hydrocephalus.Subcutaneous csf accumulation was observed around the device.The valve's patency was confirmed through radio isotopes.Therefore, the valve and the catheter were removed and replaced.When implanting the new ventricular catheter, the insertion location was changed from frazier¿s point to koccher¿s point.It was stated that, the surgeon could not think of the causation of subcutaneous retention other than the valve breakage.It was confirmed that the valve was not broken, however, there was a suspicion of ventricular catheter blockage.The patient is currently in follow up.According to information provided, it is unknown if the patient experienced any signs and symptoms due to suspected catheter blockage.
Additional Manufacturer Narrative
The hakim ventricular catheter (id 823041) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated, no occlusion noted.Root cause analysis ¿ the possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the catheter.At the time of investigation, no function issues were noted.
Event or Problem Description
N/a.

• 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: 20051374
• Report Number: 3013886523-2024-00247
• Device Sequence Number: 15443725
• 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 Implanted Year: 2024
• 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): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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: CERTAS PLUS (ID 828814)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown