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

Catalog Number	826631
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
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 that on (b)(6) 2024, an icp microsensor (id 826631) was implanted.When the physician was about to close the implantation site, the microsensor broke into several pieces after the physician gently pulled the microsensor.Therefore, the sensor was retrieved and the patient's ico could not be monitored.
Additional Manufacturer Narrative
The microsensor (id 826631) was returned for evaluation.Device history record (dhr) - the product code 826631 with lot 7258178 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the catheter received in two pieces; cut/torn apart.No testing possible.The complaint was confirmed.Root cause analysis - the possible root cause for this issue reported by the customer could be due to probe connector housing is impacted by external force and could also be due to mishandling of the catheter.

• Brand Name: NEUROMONITOR BASIC KIT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20473494
• Report Number: 3013886523-2024-00323
• Device Sequence Number: 7471796
• Product Code: GWM
• UDI-Device Identifier: 10381780520412
• UDI-Public: (01)10381780520412(17)280531(10)7258178
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 826631
• Device Lot Number: 7258178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICO EXPRESS MONITOR ID 826635; ICP EXPRESS CABLE ID 826636
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian