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

Catalog Number	826653
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
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) 2025.The microsensor was broken when the patient returned to the ward.Therefore, the patient was sent back to receive the revision procedure to remove and replace the sensor on (b)(6) 2025.All the broken parts were removed from the patient.The patient did not experience any signs or symptoms due to the device issue and is stable.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id 826653) was returned for evaluation and a photo was provided: device history record (dhr) - the product code 826653 with lot 7250011, conformed to the specifications when released to stock.Failure analysis - the device was evaluated both via the image sent by the customer and once the device was returned, the complaint can be confirmed.The device appears to have been cut or crimped.Root cause analysis - the most likely cause is mishandling of the device.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Common Device Name: ICP MICROSENSORS (ROHS)
• 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: 21483102
• Report Number: 3014334038-2025-00023
• Device Sequence Number: 3995332
• 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: 2025
• Device Explanted Year: 2025
• 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): 11/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 826653
• Device Lot Number: 7250011
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian