MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN); INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER

Model Number	IC-3893AE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the icy catheter (lot # 198849) suspected leak was not confirmed during the visual and functional testing of the returned icy catheter.No issues or discrepancies were found.No leak, no damage, no device malfunction was observed during testing, and the catheter functioned as intended.Functional testing of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi; no leak and no issues were found on the catheter.The balloon did not leak during testing.In addition, the returned catheter was connected to a known- good suk and ran on a peristaltic pump for 10 minutes at a high-speed rate.No leak was observed, and the catheter functioned as intended.During further functional testing, the returned catheter was connected to a known-good suk and ran on the thermogard console system, running in the max warming mode with a target temperature at 37°c for 60 minutes and running in the max cooling mode with a target temperature at 35°c for 60 minutes.No leak was observed on the catheter.The balloons were properly warming during the warming mode and cooling during the cooling mode.The red pinwheel of the suk was spinning as normal.No problem was found, and the catheter functioned as intended.
Event or Problem Description
Ivtm therapy was initiated using an icy catheter (lot# 198849).During the therapy's fever mode, the console displayed an air trap alarm, and the saline bag (with approx.200ml) was found to be empty.Consequently, the therapy was discontinued, the catheter was removed, and no alternative temperature management therapy was administered.According to the reporter, the console remains fully functional and ready for clinical use.The patient's status information was requested but the customer did not provide a response.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN)
• Common Device Name: INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 21870169
• Report Number: 3010617000-2025-00263
• Device Sequence Number: 8728821
• Product Code: NCX
• UDI-Device Identifier: 00849111075251
• UDI-Public: 00849111075251
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2025

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 Expiration Date: 06/01/2026
• Device Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 198849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown