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

Catalog Number 826850

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that on (b)(6) 2019, a lego icp probe item no.826850, had issues with sensors not reading correctly and apparently giving negative readings.Upon placement in patient gave readings of -46 mmhg alarming that cable issue detected.Registrar changed cerelink unit and cable for another new monitor and still had same issue.Registrar removed sensor 1, opened up new sensor (#2), again zero¿d which was successful.

Manufacturer Narrative

The microsensor was received for evaluation.Review of the history device records was not possible as the lot number was not found in our system failure analysis - the issue of the complaint has not been confirmed.The catheter was evaluated and the following observations were noted: the catheter passed all testing performed.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 unstable sensor performance or incorrect selection of semiconductor components.

• Brand Name: LEGO 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
• MDR Report Key: 8887253
• MDR Text Key: 154124545
• Report Number: 1226348-2019-00327
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826850
• Device Lot Number: 3362989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR