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

Catalog Number	826852
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2023
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 icp microsensor was placed via metal skull bolt on (b)(6) 2023.On (b)(6) 2023, the icp xpress unit read and icp mean of 0 to -1, and the waveform on the patient monitor fluctuated between -5 to 5.Patient sedated with propofol and fentanyl, equally reactive pupils.The patient was bronched prior to calling clinical specialist, and patient¿s heart rate increased during the bronch but the icp remained -1 to 0.Charge nurse inspected lead wire of sensor and reported that it appeared intact.The zero-reference number was correctly entered into the icp express unit.The nurse was advised through re-synchronizing both monitor, changed patient cable and monitor.However, all troubleshooting techniques failed to elicit a different outcome.Therefore the nurse was advised that it was likely a sensor issue, either dislodged or damaged in a way not easily visible and to notify the physicians.The sensor was removed for inaccurate readings and was not replaced.The patient remains in serious, but stable condition.Clinical questionnaire received: implant location: parenchymal.Hospital location of implant: icu.Did the failure occur during patient movement? (i.E.Reposition, transport, out of bed for bathroom, ambulate, chair, etc.): no.Did the patient receive an mri or ct scan before the failure occurred? ct scan.When the failure occurred, was the integra/codman icp monitor plugged into the wall? yes.When the failure occurred, was the integra/codman icp monitor connected to a patient monitor? yes.When the failure occurred, where was the integra/codman icp monitor positioned: iv pole other devices implanted in the head? (shunt, evd, subdural drain).No.Was more than 1 integra/codman icp monitor used for the sensor? during troubleshooting the patient cable and monitor were changed out with no impact on icp value or waveform.
Additional Manufacturer Narrative
The cerelink icp microsensor (id 823045) was returned for evaluation.Device history record (dhr) - product 826852 for lot 6162676 (sn 133847), and the lot 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 was acceptable; icp express read 438.The device passed electronic, noise, linearity/hysteresis and signal drift tests.Root cause - the root cause of the issue reported by customer could not be determined as the device worked correctly.

• 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 ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; ch-2400; mansfield MA ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17551638
• Report Number: 3013886523-2023-00269
• Device Sequence Number: 6695351
• Product Code: GWM
• UDI-Device Identifier: 10381780520696
• UDI-Public: (01)10381780520696(17)240131(17)6162676
• Combination Product (Y/N): N
• PMA/510(K) Number: K173192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 01/31/2024
• Device Catalogue Number: 826852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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