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	Cerebral Edema (4403)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
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
1 of 3 reports: other mfg report numbers: 3014334038-2025-00039, 3014334038-2025-00040.A facility reported: "codman measurement does not work.Must be reset multiple times.Patient critically ill with labile icp without possibility of measurement on evd.Codman changed x 3 during day shift and beginning of evening shift.Measurement is seen at one point on codman, but cannot be displayed on screen." "finally, with the help of the anesthesia nurse (fetched several codman) it is possible to get the correct measurements.During shift, patient has developed pupil diff due to increasing edema and codman has not shown correct measurement.Neither on codman nor screen." patient was urgently taken to the or for evd placement.Consequence of the incident: medical or surgical treatment.Were other medical devices used in connection with the incident (e.G.Accessories)? yes.Several serial numbers in use in the department: (b)(6), etc.Cables to and from the icp electrode in the brain and the one out to the screen can be replaced between the different icp monitors.Icp sensor (the electrode in the brain) that connect to the icp monitor: cerelink (tm) icp sensor, reference number (b)(4).
Additional Manufacturer Narrative
The cerelink sensor was not returned for evaluation after three good faith attempts (gfes) were made.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.

• 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: 21664949
• Report Number: 3013886523-2025-00055
• Device Sequence Number: 12666236
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: 10381780520689
• 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): 06/13/2025

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: 826851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICP EXPRESS MONITOR, 220 VOLT (ID 826635).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown