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	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The icy catheter associated with this complaint was not returned for evaluation.A follow-up report will be submitted when the product is returned and investigation has been completed.Seems that around 350 ml of sterile cold saline were entered 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 customer could benefit from additional training on how to handle suspected catheter leak.The fluid ran into the patient's vasculature is an anticipated event.Based on available information, no patient's effect was observed.
Event or Problem Description
Ivtm therapy was initiated using an icy catheter (lot # 202910).During treatment, the thermogard console was reported to be noisy.At an unspecified time, the saline bag was found to be empty.The bag was replaced, and during one hour, a drop in the saline level was observed.The patient received approximately 250 ml of saline infusion from the first bag and an additional 50-100 ml from the second bag.The customer suspected saline leakage from the icy catheter.According to the reporter, the catheter leak check, as outlined in the instructions for use (ifu), was not performed.No consequences or impacts on the patient.
Additional Manufacturer Narrative
The reported complaint of the icy catheter (lot # 195238) leak was confirmed during functional testing.A pinhole leak was observed at the middle of the medial balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.During the functional pressure leak test all infusion ports and lumens were flushed without resistance.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 pinhole leak was observed at the middle 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 information related to the reported complaint, and no similar complaints were reported for the icy catheter with lot number 195238.Correction: b5 and d4, lot # for catheter.
Event or Problem Description
Ivtm therapy was initiated using an icy catheter (lot # 195238).During treatment, the thermogard console was reported to be noisy.At an unspecified time, the saline bag was found to be empty.The bag was replaced, and during one hour, a drop in the saline level was observed.The patient received approximately 250 ml of saline infusion from the first bag and an additional 50-100 ml from the second bag.The customer suspected saline leakage from the icy catheter.According to the reporter, the catheter leak check, as outlined in the instructions for use (ifu), was not performed.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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 23035569
• Report Number: 3010617000-2025-00620
• Device Sequence Number: 9217106
• Product Code: NCX
• UDI-Device Identifier: 00849111075251
• UDI-Public: 00849111075251
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/08/2025

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: 09/25/2025
• Device Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 195238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• 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