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

Model Number	IC-3893
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot 203311) was not confirmed during functional testing.No issues or discrepancies were found.No leak, damage, or device malfunction was observed during testing, and the catheter functioned as intended.Visual inspection of the returned catheter was performed.There was no physical damage observed on the catheter.Functional testing of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During 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, 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
The customer reported an issue yesterday during ivtm therapy using the icy catheter (lot 201524).The saline bag went half empty.No blood was noted in the circuit or the saline bag.There was no observable leak outside the patient.The catheter was disconnected, and the md was notified.The patient was completed with ttm but the femoral line was being used for iv access.The patient was persistently hyperthermic, as he was febrile, so the nurse was given the okay to use the icy catheter for temperature management.The patient was reconnected to the console and the decrease in volume of the saline bag was noticed about half an hour later.The catheter was removed, and a cooling blanket was used instead.The catheter was placed on (b)(6) 2025 at 0105 without issues during insertion.It was removed on (b)(6) 2025 at 1705.No impact to the patient.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (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 ; 4084192947
• MDR Report Key: 22342742
• Report Number: 3010617000-2025-00434
• Device Sequence Number: 4901473
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 10/31/2025
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 201524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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