MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERELINK ICP PROBE BASIC KIT; ICP MICRSOSENSORS - CERELINK

Catalog Number 826850

Device Problem High Readings (2459)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2023

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

This is 1 of 4 reports linked to mfg report numbers: 3014334038-2023-00040; 3014334038-2023-00041; 3013886523-2023-00091.A facility reported a cerelink sensor (id 826850) was implanted in operative room for monitoring intracranial pressure (icp) of an acute subarachnoid hemorrhage, but once the dressing was placed, the reading became abnormally high.A new cerelink sensor was inserted and the readings were stable.Patient was transferred to icu but overnight, the readings became abnormally high and erratic.Medication was given to bring icp down, however the patient did not respond, although did not appear to be symptomatic either.The sensor was removed at bedside on (b)(6) 2023 and an evd was inserted which gave a normal icp reading.

Manufacturer Narrative

The cerelink sensor (id 826850) was returned for evaluation.Device history record (dhr) - lot 6427640 (sn (b)(6)) met specifications when released.Failure analysis - the complaint was not confirmed.There was no visible damage to the millar sensor, catheter material, or connector.The cerelink monitor was acceptable, icp express read 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.However, the possible root cause of the defect reported by the customer could be due to excessive pressure applied to product.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• Type of Device: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16655816
• MDR Text Key: 312433742
• Report Number: 3013886523-2023-00090
• Device Sequence Number: 1
• Product Code: GWM
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 826850
• Device Lot Number: 6485652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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