MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number 826633

Device Problem Mechanical Problem (1384)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

A facility reported the luer-fitting of an icp sensor cannot be fixed during procedure, before implantation site closure.The procedure was completed with a replacement product available.No patient consequences reported and the event led to 15 minutes surgical delay.The monitor used was icp express, 220 volt (id (b)(4).) and the cable used was icp express cable (id (b)(4).).

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Microsensor (id 826633) was not returned for evaluation as the product was discarded as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.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: ICP SENSOR CATHETER KIT
• Type of Device: ICP MICROSENSORS
• 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: 17596607
• MDR Text Key: 321776234
• Report Number: 3014334038-2023-00142
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780520436
• UDI-Public: 10381780520436
• Combination Product (y/n): N
• PMA/PMN Number: K991222
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826633
• Device Lot Number: 6248680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2023
• Date Device Manufactured: 04/13/2022
• 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
• Treatment: ICP EXPRESS CABLE (ID 826636); ICP EXPRESS, 220 VOLT (ID 826635)