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

Catalog Number	826851
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
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: when a sensor (id 826851) was inserted, the cerelink monitor gave error message "sensor or cable faulty" nurses tried changing icp monitor (826820) and icp extension cable (826845) but nothing worked.After taking a new sterile sensor everything worked fine.The procedure was completed with a replacement product available.No patient injury reported and the event led to 30 minutes surgical delay due to product problem.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor was returned for evaluation: dhr - lot 7365432; sn (b)(6) conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was not confirmed: - foreign matter over sensor area.- catheter crimped 44.4 and 67.4 cm from distal end.- icp express read 546 and zeroed without any issues.- the device passed electronics, noise, linearity/hysteresis and signal drift tests.Root cause - the exact issue reported by customer could not be confirmed as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to incorrect set-up of device.Furthermore, the foreign matter may have possibly caused this anomaly.
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: 22061373
• Report Number: 3013886523-2025-00111
• Device Sequence Number: 15363427
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(17)280331(10)7365432
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 826851
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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 EXTENSION CABLE - ID 826845.; ICP MONITOR - ID 826820.
• Patient Sex: Unknown