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

Model Number	826852
Medical Device Problem Codes	No Device Output (1435); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
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.
Additional 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 or Problem Description
N/a.
Additional 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
• 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: 14167035
• Report Number: 3013886523-2022-00182
• Device Sequence Number: 5025056
• Product Code: GWM
• UDI-Device Identifier: 10886704075455
• UDI-Public: 10886704075455
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 826852
• Device Catalogue Number: 826852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 04/22/2022; 06/16/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/18/2022; 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown