MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L M BOLT; ICP MICRSOSENSORS - CERELINK

Catalog Number	826851
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 2 reports.Other mfg report number: 3013886523-2025-00281.A facility reported that the icp measuring was "failing".The cerelink sensor (id 826851) came loose from directlink module (id 826828).The fault was reported after disconnecting the sensor module to go to ct: reconnection did not give the correct value despite following the steps.Normally, medical staff should be able to make connection again with the patient monitor but, even after several attempts, this unit did not work (orange button remains led).Therefore, the sensor was explanted and replaced.Reason for patient monitoring: "excessive pressure requiring removal of skull flap, remaining comatose.".
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 cerelink sensor was returned for evaluation: dhr - conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was not confirmed: - foreign matter over sensor area, no cleaning needed.- catheter crimped 35.5 cm from connector end.- catheter crimped 5.2, 12.8 and 14.2 cm from distal tip.- icp express = 535, cerelink monitor ¿ acceptable; microsensor detected and zeroed without any issues.- the device passed electronic, noise and signal drift tests.Root cause - the exact issue reported by customer could not be confirmed as the device worked correctly.One possible root cause of the defect reported by the customer could be due to the crimp at 35.5 cm from connector; if the catheter was still crimped by the forceps, the pressure could have possibly caused the unit not to respond when trying to reconnect.Could also be due to a sensor malfunction.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• Common Device Name: ICP MICRSOSENSORS - CERELINK
• 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: 23266832
• Report Number: 3013886523-2025-00280
• Device Sequence Number: 15991157
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(17)270131(10)7508828
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/21/2026

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: 826851
• Device Lot Number: 258421
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: DIRECTLINK MODULE ID 826828.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown