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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of suspected catheter leak was confirmed during the functional testing of the returned icy catheter (lot#: 205971).During the functional pressure leak test, a bonding leak and a pinhole leak were observed at the proximal end of the distal balloon.The probable root cause of the bonding leak is a latent defect in the bond, and the probable root cause of the pinhole leak is a latent material defect.During the functional leak test of the returned catheter, all infusion ports and extension tubes 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.Upon pressurizing the catheter, a bonding leak was observed at the proximal end of the distal balloon, and a pinhole leak was located 2 cm away from the proximal end of the distal balloon, confirming the reported complaint.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for investigation results related to the reported complaint, and there was no previous history of complaints reported for the icy catheter with lot number: 205971.
Event or Problem Description
A patient received ivtm therapy for fever management.The icy catheter (lot#: 205971) was smoothly inserted into the patient's right femoral vein in a single attempt.No adjunctive temperature management or relative procedures were performed on the patient prior to the ivtm treatment.The patient's body temperature at the beginning of the treatment was 39.1 °c, and the target temperature was set at 37.5 °c to cool the patient.Seventy hours after the initiation of the treatment (cooling the patient), the thermogard system generated an "air trap" alarm.The pump rotor stopped, and the console entered standby mode.The customer noticed that the 500-ml saline bag was empty.No saline solution was observed on the floor, the patient's bed, or the console.There was no blood tinge in the suk tubing.However, the customer suspected that 250 ml of saline had infused into the patient's bloodstream from the catheter.The catheter was replaced.There were no issues with the thermogard console used during the event.No patient injury was reported.No consequences or impacts on the patient.

• 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: 22023071
• Report Number: 3010617000-2025-00349
• Device Sequence Number: 21203257
• 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): 05/14/2025

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: 08/11/2026
• Device Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 205971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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: Male
• Patient Weight: 109 KG