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

Model Number 826852

Device Problems No Device Output (1435); Low Readings (2460)

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

Event Date 04/18/2022

Event Type  Injury  

Event Description

A facility reported a cerelink microsensor was inserted with icp express and after a few minutes with positive icp values, the icp went down to -50 and stop monitoring.Even switching icp express, and replacing the zero, values were not displayed.The sensor was retrieved.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Additional information received: the probe insertion was the 17th and the issue came out the 18th.They started monitoring the patient with an icp express, and after the failure they explanted the sensor and implanted a new one and use another icp express on (b)(6).At the moment the patient is still monitored.

Event Description

N/a.

Manufacturer Narrative

Complaint sample was not returned for evaluation (discarded) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined; however, the possible root cause for the issue reported by the customer could be due to excessive pressure applied to product.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• 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: 14167035
• MDR Text Key: 289744262
• Report Number: 3013886523-2022-00182
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10886704075455
• UDI-Public: 10886704075455
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2022

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 Model Number: 826852
• Device Catalogue Number: 826852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 04/22/2022; 06/16/2022
• Supplement Dates FDA Received: 05/18/2022; 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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