MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number	826633
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a microsensor (id 826633) could not be screwed tightly and was leaking cerebrospinal fluid (csf) at the end of the catheter's blue cap after it was implanted on (b)(6) 2024.The physician removed the sensor and stopped monitoring on the same day.It was estimated that there was a moderate amount of csf leakage.The patient did not experience any signs or symptoms due to csf leakage and is currently stable.
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, h4, h6, h11.The microsensor (id 826633) was returned for evaluation.Device history record (dhr) - reported lot number 6250936, and no anomalies were identified during the manufacture or packaging of the device.However, the returned device for failure analysis doesn¿t match the reported lot number.Therefore, we have reviewed the returned device¿s lot number 6345637 and no anomalies were identified during the manufacture or packaging of the device.Failure analysis - the catheter and sensor were inspected.No defects were observed.The fittings were inspected.The blue cap was fully tightened.A syringe with water was used to introduce fluid to the catheter.Water was observed leaking from the blue cap.Based on the evaluation, the complaint is confirmed.Root cause analysis - per the complaint background, csf leak.The complaint was confirmed during investigation and failure analysis evaluation.A potential root cause is improper cap tolerance or damage to the luer-lock connector.
Event or Problem Description
N/a.

• Brand Name: ICP SENSOR CATHETER KIT
• Common Device Name: ICP MICROSENSORS
• 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: 19734463
• Report Number: 3014334038-2024-00146
• Device Sequence Number: 20863631
• Product Code: GWM
• UDI-Device Identifier: 10381780520436
• UDI-Public: 10381780520436
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 826633
• Device Lot Number: 6345637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2022
• 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: ICP CABLE (ID 826636).; ICP MONITOR (ID 826635).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian