MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP PROBE 1L P BOLT; ICP MICRSOSENSORS - CERELINK

Model Number	826852
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
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
A facility reported a cerelink microsensor (id 826852) was implanted in the operative room in a (b)(6) female patient and connected to the icp express monitor.During the first 24 hours the sensor was correctly working and the icp express gave reliable pressure data.Then the patient was transferred to the angiographic room.In the angiographic room and after 24 hours from the implantation, the monitor displayed the following error ¿sensor not detected¿ and it definitely stop working the sensor was removed and a new one was implanted and connected to a cerelink monitor.Actually, the new one is working.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 cerelink sensor was returned for evaluation: dhr - lot 5464252 conformed to the specifications when released to stock failure analysis - no visible damage to the millar sensor, catheter or connector.Cerelink monitor reading was acceptable; icp express passed with reading 543.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.Issue has not been confirmed for this device.The root cause of the issue reported by customer could not be confirmed as the sensor passed all testing after cleaning.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE 1L P BOLT
• Common Device Name: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14141354
• Report Number: 3013886523-2022-00166
• Device Sequence Number: 6291212
• Product Code: GWM
• UDI-Device Identifier: 10381780520696
• UDI-Public: (01)10381780520696(17)230331(10)5464252
• 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): 08/16/2022

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 Expiration Date: 03/31/2023
• Device Model Number: 826852
• Device Catalogue Number: 826852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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 Age: 54 YR
• Patient Sex: Female