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

Catalog Number	826851
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cerelink sensor (id: 826851) was returned for evaluation.Device history review: the product code: 826851 with lot: 7573812, sn: (b)(6) conformed to specifications when released to stock.Failure analysis: the issue of the complaint was confirmed: received with sutures.The catheter was kinked at 2.6 cm and 12.5 cm from distal tip.Foreign matter observed on the connector.Internal wires broken.No further testing possible.Root cause analysis: the possible root cause for this issue reported by the customer could be due to mishandling of the catheter while moving the patient.
Event or Problem Description
A facility reported a cerelink sensor (id: 826851) was implanted.The device stopped reading after being implanted for several days, while the nursing staff was boosting patient in bed.Sensor was not retrieved due to the event.Additional information: implant location (ex: parenchyma): parenchyma.Was the integra/codman icp monitor connected to a patient monitor: yes.If yes, provide patient monitor make & model: drager.Was the patient lead always connected: most of time, rn did not it came off around the time of failure while boosting patient in bed.What was happening with patient: sensor momentarily showed 149 for icp, then immediately went into cable failure mode.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• Common Device Name: ICP
• 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: 24843968
• Report Number: 3013886523-2026-00080
• Device Sequence Number: 5585753
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: (01)10381780520689(11)250722(17)270630(10)7573812
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: 826851
• Device Lot Number: 7573812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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
• Patient Sex: Female