MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. CERELINK ICP EXT CABLE; CERELINK - CABLES

Catalog Number	826845
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
1 of 3 reports.Other mfg report numbers: 3014334038-2025-00028.3014334038-2025-00029.This report is for cerelink icp ext cable id 826845: a facility reported a cerelink system started to have an unreliable increase in the pic value up to 40, patient had a ct scan exam which showed icp of 80.The real correct icp value for this patient was 15/20.From an angiographic exam, the catheter seemed bent.; therefore, it was removed and replaced on (b)(6) 2025; one day after implantation.Patient in stable condition after replacement.The monitor did not show any error message.
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
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The cerelink cable was returned for evaluation: dhr - no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed failure analysis - upon inspection, the cable failed due to the presence of a blood-like substance and a cut observed in the insulation.A functional test could not be performed due to the potential contamination risk.This was due to the absence of a decontamination certificate accompanying the returned cable, as well as the presence of a blood-like stain.Complaint indicates: the cerelink device is currently being used with a yellow extension cable.It has been clarified that the correct cerelink cable is part number 826845.The "substitute yellow cable"referenced in the complaint is an extension cable provided by the representative following the incident and is not the cable associated with the original complaint.Root cause: incorrect ext cable used in the field.

• Brand Name: CERELINK ICP EXT CABLE
• Common Device Name: CERELINK - CABLES
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21483113
• Report Number: 3006697299-2025-00024
• Device Sequence Number: 19822481
• Product Code: GWM
• UDI-Device Identifier: 10381780520665
• UDI-Public: (01)10381780520665(11)230921(10)7307074
• Combination Product (Y/N): N
• PMA/510(K) Number: K210993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 11/14/2025

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 Catalogue Number: 826845
• Device Lot Number: P138970001
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown