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

Model Number 826852

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  Injury  

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 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.

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 Description

N/a.

• Brand Name: CERELINK ICP PROBE 1L P BOLT
• Type of Device: 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
• MDR Text Key: 289500051
• Report Number: 3013886523-2022-00166
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780520696
• UDI-Public: (01)10381780520696(17)230331(10)5464252
• Combination Product (y/n): N
• PMA/PMN Number: K173192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female