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	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter in the complaint was returned to zoll on 14 october 2025 for evaluation.However, the investigation is still in progress.A follow-up report will be submitted when the investigation is completed.
Event or Problem Description
The icy catheter (lot # unknown) was smoothly inserted into the patient's right femoral vein in a single attempt to initiate hypothermia after cardiac arrest.No other temperature management or related procedures were performed on the patient prior adjunct or prior to the ivtm therapy.After 15 hours, the thermogard xp ivtm system generated an "air trap" alarm.Upon inspection, it was noticed that blood was returning to the tubing.The catheter balloon was defective and leaking.The treatment was finished, and therefore, the catheter was not replaced.There is no device malfunction on the thermogard console; it is functional, and it has been placed back on the floor for future clinical use.No patient injury was reported, and the patient is ventilated and stable.
Event or Problem Description
The icy catheter (lot # 211380) was smoothly inserted into the patient's right femoral vein in a single attempt to initiate hypothermia after cardiac arrest.No other temperature management or related procedures were performed on the patient prior adjunct or prior to the ivtm therapy.After 15 hours, the thermogard xp ivtm system generated an "air trap" alarm.Upon inspection, it was noticed that blood was returning to the tubing.The catheter balloon was defective and leaking.The treatment was finished, and therefore, the catheter was not replaced.There is no device malfunction on the thermogard console; it is functional, and it has been placed back on the floor for future clinical use.No patient injury was reported, and the patient is ventilated and stable.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated.D4 (suspect medical device, lot # and expiration date) was updated.D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.H6 codes were updated.The reported complaint of a catheter leak was confirmed during functional testing of the returned icy catheter (lot # 211380).A bonding leak was observed at the distal end of the medial balloon during the pressure leak test.The probable root cause of the complaint could be a latent defect in the bond.During the functional leak test, all infusion ports and lumens were flushed without resistance.During the 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 distal end of the medial 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 211380.

• 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: 23418418
• Report Number: 3010617000-2025-00744
• Device Sequence Number: 8946056
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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 Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 211380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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
• Patient Sex: Female