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
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 facility reported a microsensor (id 826633) was implanted on (b)(6) 2024.On (b)(6) 2024, the physician found that the blue cap at the end of the catheter was leaking cerebrospinal fluid (csf) and the physician used gauze to wrap where was leaking csf.On (b)(6) 2024, it was still leaking csf at the blue cap.Then the physician retrieved the device and stop monitoring.The patient did not experience any signs or symptoms due to csf leakage and is currently stable.
Event or Problem Description
N/a.
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) - the batch record was reviewed for any anomalies or nonconformances, during production, related to the finished device.None were identified related to this report.Failure analysis - a visual inspection was performed; no defects were found.A water filled syringe was connected drainage port and water was injected into the catheter.A leak was observed at the blue cap.The complaint was confirmed.Root cause analysis - the potential root cause is improper cap tolerance.

• 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: 19731516
• Report Number: 3014334038-2024-00145
• Device Sequence Number: 8274538
• 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): 09/19/2025

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: 6250936
• 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: 08/28/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian