MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR NEUROMONITOR BASIC KIT; ICP MICROSENSORS

Model Number 826631

Device Problem Connection Problem (2900)

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

Event Date 10/27/2022

Event Type  malfunction  

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

A facility reported a microsensor (id 826631) could not be detected.The issue occurred during procedure before the implantation site closure.The physician change the a new icp monitor (id 8226635) and cable (id 826636) however, it still could not detect the microsensor.Therefore, they replaced a microsensor.No patient injury reported and the event did not led to surgical delay.

Event Description

N/a.

Manufacturer Narrative

The microsensor (id 826631) was returned for evaluation.Failure analysis - the issue of the complaint was not confirmed.The connector cut/torn from catheter exposing internal wires.The catheter stretched and mashed at sensor end.No testing was possible.The root cause of the issue reported by customer could not be determined as no testing was possible due to the condition of the catheter received.However, the possible root cause for this issue reported by the customer could be due to excessive pressure applied to product.

• Brand Name: NEUROMONITOR BASIC KIT
• Type of Device: ICP MICROSENSORS
• 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: 15870369
• MDR Text Key: 307295311
• Report Number: 3013886523-2022-00554
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: 10381780520412
• Combination Product (y/n): N
• PMA/PMN Number: K914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 826631
• Device Catalogue Number: 826631
• Device Lot Number: 5323192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2021
• 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