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

Model Number	IC-3893
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During ivtm treatment, the registered nurse (rn) found that the saline bag attached to the icy catheter (lot #unknown) was empty.No saline was on the floor or in the bed, so the customer assumed some saline might have infused into the patient's body.A possible catheter leak was suspected.No further information was provided.The patient's status information was requested, but the customer did not provide a response.
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.The reported complaint of a possible catheter leak was not confirmed during visual and functional testing of the returned icy catheter (lot #204218).No issues or discrepancies were found.No leak or malfunction was observed during testing, and the catheter functioned as intended.A functional pressure leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance, except for the proximal infusion luer port due to the blood clogging inside the tubing.The catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi; no leaks or issues were found.In addition, the returned catheter was connected to the returned suk and ran on a peristaltic pump for 10 minutes at a high-speed rate; no leak was observed.The suk red pinwheel rotated as normal, and the catheter functioned as intended.During further functional testing, the returned catheter was connected to the returned suk and ran on the thermogard console system, running in max warming mode with a target temperature of 37°c for 60 minutes and in max cooling mode with a target temperature of 35°c for 60 minutes.The balloons were properly warmed during the warming mode and cooled during the cooling mode.No leaks or damage were found on the catheter.The suk red pinwheel and the pump roller rotated as normal, and the catheter functioned as intended.
Event or Problem Description
During ivtm treatment, the registered nurse (rn) found that the saline bag attached to the icy catheter (lot #204218) was empty.No saline was on the floor or in the bed, so the customer assumed some saline might have infused into the patient's body.A possible catheter leak was suspected.No further information was provided.The patient's status information was requested, but the customer did not provide a response.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE (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: 21554318
• Report Number: 3010617000-2025-00175
• Device Sequence Number: 19952061
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 10/31/2025
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: 204218
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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