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	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a microsensor (id 826633) was implanted on (b)(6) 2024.After the procedure, the physician found that he could not lock the female connector into the adapter, it was identified that the threads were slightly warped causing a failure to completely lock the lure connector.Therefore, the csf was leaking from the lure connector, the physician tried to use the tape to wrap the lure connector.Three days later, there was still minimal csf leaking.On (b)(6) 2024, the physician retrieved the microsensor and stop monitoring.The patient is 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) - review was performed on reported lot number 6923882, 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 dhr for returned device¿s lot number 6345637 and no anomalies were identified during the manufacture or packaging of the device.Failure analysis - the catheter and microsensor were visually inspected.All luer connectors were visually inspected.No defects were observed.None of the threads appeared to be warped.The catheter was then connected to a syringe filled with water.The tip of the catheter was clamped with a hemostat, and pressure was applied using the syringe.No leaks were observed.Root cause analysis - per the complaint background, csf leaking.The complaint was not confirmed during investigation and failure analysis evaluation.Per risk documentation a potential root cause is improper cap tolerance or mishandling.
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: 20042638
• Report Number: 3014334038-2024-00172
• Device Sequence Number: 7895860
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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 (826636).; ICP MONITOR (826635).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian