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	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The microsensor was returned for evaluation: - dhr - no anomalies were identified that occurred during the manufacture or packaging of the device.- failure analysis - received partial catheter, cut/torn/crimped from drainage tube.No testing possible.- root cause - the complaint was confirmed, potential root cause: improper use or excessive force on product; physical strength of product unfits for intended use.
Event or Problem Description
A facility reported that during implantation procedure, the microrsensor (id 826653) broke after slightly being pulled.The physician said this microsensor was too fragile to implant into the patient.Then the physician retrieved the device and stop monitoring.The event led to 15 minutes surgical delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Follow-up to add missing field in the initial report: d9.

• 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: 22911715
• Report Number: 3014334038-2025-00119
• Device Sequence Number: 9047948
• 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
• 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): 10/21/2025

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: 826653
• Device Lot Number: 7345543
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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: CABLE - ID 826636.; MONITOR - ID 826635.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian