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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the icy catheter (lot 201202) leak was confirmed during functional testing.A water emission leak was observed from the distal end of the manifold during the lumen crosstalk test.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.Functional testing of the returned catheter was performed.All the infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi; no leak was observed from the catheter balloons.However, a water emission leak was observed from the distal end of the manifold during the lumen crosstalk test, 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 there was no previous history of complaint reported for the icy catheter with lot #201202.
Event or Problem Description
The hypothermia procedure began on (b)(6) with the insertion of an icy catheter (lot # 201202) through the right femoral vein.The catheter insertion was smooth after the first attempt.Around 9am on (b)(6) 2025, an airtrap alarm alerted nurses for a decrease of saline in the bag.Investigation revealed no visible spillage on the floor or bed, but the gauze at the catheter access site was soaked, containing watery blood.The physician suspected a leakage issue with the icy catheter and the infusion of the 200 ml of saline into the patient's bloodstream after the physician performed the catheter leak check per ifu.The new icy catheter was placed to continue the therapy with the same console.No consequences or impact to 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
• MDR Report Key: 21249490
• Report Number: 3010617000-2025-00067
• Device Sequence Number: 9116788
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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: 04/08/2026
• Device Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 201202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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: Unknown