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

Model Number	IC-3893CO
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	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In the emergency department, before placing the icy catheter (lot# 200330), balloon leakage was identified during the saline flush test performed to verify balloon integrity when the catheter was connected to the console.As a result, the catheter was immediately removed from use.An alternative temperature management therapy was utilized to continue the patient's treatment.No adverse impact to the patient.
Additional Manufacturer Narrative
Zoll has not received the icy catheter for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Additional Manufacturer Narrative
The reported complaint of a catheter balloon leak was confirmed during flushing of the returned icy catheter (lot# 197872) during decontamination.During the in/out lumen flushing, a leak was observed from the middle of the distal balloon due to a tear in the balloon.During functional testing, all infusion ports and lumens were flushed without resistance.Upon flushing the in/out lumen, a leak was observed from the middle of the distal balloon.Further inspection of the catheter under a microscope showed a balloon tear located in the middle of the distal balloon, confirming the reported complaint.Pressurized functional testing could not be performed due to the leak discovered during the in/out lumen test.Historical complaints were reviewed for investigation related to the reported complaint, and one similar complaint was reported for the icy catheter with lot #197872.Ccr 92430 was reported on 5 january 2026, and a balloon tear was observed.Correction: b5 and d4, lot # for catheter.
Event or Problem Description
In the emergency department, before placing the icy catheter (lot# 197872), balloon leakage was identified during the saline flush test performed to verify balloon integrity when the catheter was connected to the console.As a result, the catheter was immediately removed from use.An alternative temperature management therapy was utilized to continue the patient's treatment.No adverse impact to the patient.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE CUSTOM LUER
• 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: 23901443
• Report Number: 3010617000-2025-00882
• Device Sequence Number: 10116290
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/14/2026

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: 01/27/2026
• Device Model Number: IC-3893CO
• Device Catalogue Number: 8700-0782-14
• Device Lot Number: 197872
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 02/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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