MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE BASIC KIT; ICP MICRSOSENSORS - CERELINK

Catalog Number	826850
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2025
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 sales representative reported: "the pressure sensor was installed on saturday evening.Initially, there was a very nice curve (i was there).Now, less than 48 hours later, flattened curve went down to a pressure of -6.Negative pressures in the head are obviously not possible.It is also noticeable in our emv that there was a sudden drop from (what i consider to be adequate pressures of) 5-8 to 0 to -1 over the course of yesterday.And now it has dropped even further to -6.The monitoring couldn't be trusted: so we had to transfer our ventilated patient more often to radiology, plus there was no reliable continuous monitoring of the icp." the patient had more frequent cts scans due to product problem as the ventricles were too compressed to insert an evd.Patient was monitored due to severe cerebral malaria with cerebral edema.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink microsensor was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined, however, the probable root cause for the reported complaint could be ¿excessive pressure applied to product¿ or "incorrect set-up of device".If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink sensor was returned for evaluation: dhr - lot 7495600 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was confirmed : foreign matter over sensor.Received catheter in 2 pieces ; catheter and internal wires crimped/cut into 30.1 cm from distal tip (photos).Did not clean due to catheter in 2 pieces.Catheter crimped 4 cm and sutures 7.4 cm from distal tip.No further testing possible.Root cause - based on the failure analysis, the issue reported by the customer could be confirmed.The possible root cause for this issue could be ¿excessive pressure applied to product¿.However, the supplier could determine the cause of the problem stated to be mishandling of the catheter.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• 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: 23154503
• Report Number: 3013886523-2025-00261
• Device Sequence Number: 5290680
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: (01)10381780520672(17)261231(10)7495600
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 826850
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 12/15/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/26/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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 SERIAL (B)(6)
• Patient Sex: Unknown