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

Model Number 826851

Device Problem Display or Visual Feedback Problem (1184)

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

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

1 of 3 reports.(same patient, same event, same product id, different lot numbers).Other mfg report numbers: 3013886523-2022-00353; 3013886523-2022-00354.A facility reported 3 cerelink sensors which icp line disappeared and were removed/replaced.The fourth sensor (directlink) had a good signal.

Manufacturer Narrative

The cerelink sensor was returned for evaluation: dhr - lot 5895096 (sn (b)(6)) met specifications when released.Failure analysis - the issue of the complaint was not confirmed: no visible damage to the millar sensor, catheter material, or connector.Cerelink monitor reading was acceptable; icp express reading 507.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.

• Brand Name: CERELINK ICP PROBE 1L M 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: 15141848
• MDR Text Key: 297037534
• Report Number: 3013886523-2022-00352
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780520689
• UDI-Public: 10381780520689
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 826851
• Device Catalogue Number: 826851
• Device Lot Number: 5895096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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