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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The icy catheter (lot # 216479) was inserted into the patient's left femoral vein, and hypothermia treatment started around 2 pm.About an hour later, the ivtm system triggered an "air trap" alarm.Upon inspection, the doctor found that the saline level had decreased by about 200 ml.A catheter balloon leak check was performed, and the leak was confirmed.Because the patient had poor blood coagulation and bleeding at the insertion site, the catheter was not immediately removed.A new icy catheter was then placed into the patient's right femoral vein (opposite side) to continue treatment using the same console and start-up kit (suk).No further information was provided.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
The reported complaint of catheter leak was not confirmed during visual and functional testing of the returned icy catheter (lot # 216479).No issues or discrepancies were found.No leak, no damage, and no device malfunction was observed during testing, and the catheter functioned as intended.During functional testing of the returned catheter, all infusion ports and lumens were flushed without resistance.During a functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloon was 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 flow rate of 240 ml/min.No leak was found, 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 of 37°c for 60 minutes and running in the max cooling mode with a target temperature of 35°c for 60 minutes.No leak was observed on the catheter.The balloon was 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.It was reported that around 200 ml of sterile cold saline was entered into the patient's vasculature.No patient injury reported.Administration of saline i.V.Is one of the common methods of treatment at the hospitals and should not harm a patient.The event of the fluid running into the patient was causally related to the device and to the procedure.The event of bleeding at the insertion site was not serious; it was not reported that the event required treatment to prevent permanent impairment.The event of bleeding was possibly related to the icy catheter due to relevant timing and location at the time of insertion.The event was probably also related to the patient's clinical condition of poor blood coagulation.The event was not related to the procedure.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 24845943
• Report Number: 3010617000-2026-00211
• Device Sequence Number: 8946582
• Product Code: NCX
• UDI-Device Identifier: 00849111075251
• UDI-Public: 00849111075251
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/10/2026

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 Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 216479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown