MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICROSENSOR VENTRICULAR CATHETER KIT; ICP MICROSENSORS (ROHS)

Catalog Number	826653
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
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 a microsensor (id 826653) was implanted on (b)(6), 2023.The sensor was working normally during the procedure, however, when the patient was sent back to the ward, the icp monitor could not detect the microsensor.Therefore, the physician retrieved the microsensor on (b)(6), 2023 and stop monitoring.The patient did not experienced any sign and symptoms due to sensor issue.The sensor was not replaced and the patient is stable.
Additional Manufacturer Narrative
The microsensor (id 826653) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the returned unit passed all functional testing and the complaint condition was not able to be replicated.The complaint could be verified through failure analysis.Root cause analysis ¿ no root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.A potential root cause for this failure is user unaware of proper use, or user does not push connector all the way down.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Common Device Name: ICP MICROSENSORS (ROHS)
• 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: 17927386
• Report Number: 3014334038-2023-00167
• Device Sequence Number: 6352288
• Product Code: GWM
• UDI-Device Identifier: 10381780520566
• UDI-Public: 10381780520566
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 826653
• Device Lot Number: 6248677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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
• Patient Sex: Unknown