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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cerelink sensor was not returned for evaluation (is not available for return as per customer) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.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
1 of 6 reports.Other mfg report numbers: 3013886523-2025-00165; 3013886523-2025-00166; 3013886523-2025-00167; 3013886523-2025-00168; 3013886523-2025-00169.This report is for the 1st event (cerelink icp probe).A physician expressed a loss of confidence in cerelink icp sensors.They estimate that in 50% of the cases where a patient had an cerelink icp sensor and a check of icp with a fft (fluid filled transducer) via the external drainage system they noticed a decline and difference that becomes bigger and bigger (cfr drift) after a couple of days.They double check the fft measurement as this is positioning (hight) dependant, however don't notice mistakes with evd system, so they concluded wrong measurement of cerlink sensor (use this together with directlink).Additional information received: - is it possible to know how many times this type of dysfunction was observed? if yes, how many and approximate date? answer: they estimate 50% of the case, and as i count 38 probes since 2023.I believe 18 would be an educated estimation.- for each case, did they remove the sensor? how did they follow the monitoring? answer: they noticed the inconsistency as they simultaneously measured icp with a fluid filled transducer on their system for external drainage.So, they kept the sensor in as long as possible to keep measuring icp in 2 ways, relying more on fft than cerelink.- for each patient, were there any consequences? if yes, please describe.Answer: for some patient they saw that the icp wave was ¿flattened¿, and as a consequence not reliable anymore so they switched to evd (probably earlier) so some of those procedures could have been avoided if sensor was working as expected.(then a placement of external drainage could have been avoided.

• 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: 22472347
• Report Number: 3013886523-2025-00164
• Device Sequence Number: 7904916
• Product Code: GWM
• UDI-Device Identifier: 10381780520672
• UDI-Public: 10381780520672
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 826850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown