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

Model Number	IC-3893
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of difficulty advancing the catheter was confirmed during functional testing.During testing, the returned guidewire was tested with the returned catheter, and significant resistance was felt while attempting to advance the catheter over the guidewire.The root cause of the difficulty advancing the catheter was due to a kinked guidewire, likely attributed to user handling.During the visual inspection of the returned catheter, blood residue was noted on the catheter's balloons.No kinks or physical damage were found on the catheter, and no damage was observed to the catheter's balloons.During functional testing of the returned catheter, all infusion ports and lumens were flushed without any resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloons were fully inflated while pressurized up to 100 psi.No leaks or issues were found, and the catheter functioned as intended.During the functional testing, the returned guidewire was tested with the returned catheter.Significant resistance was encountered while trying to advance the catheter over the guidewire, confirming the reported complaint.This issue was due to multiple kinks located along the middle of the returned guidewire.An additional guidewire test was performed: a known-good zoll guidewire was slowly inserted through the central lumen of the catheter, starting at the catheter tip and exiting through the distal infusion luer port without any resistance.The guidewire passed through the entire length of the lumen with no resistance.Historical complaints were reviewed for investigation results related to the reported complaint, and there were no similar complaints reported for the icy catheter with lot number 196374.
Event or Problem Description
The advanced practice provider reported difficulty advancing the icy catheter (lot #196374) over the guidewire into the patient's femoral vein.The customer reported that after placing the guidewire in the vessel, they encountered significant resistance while attempting to advance the catheter.The customer stated that they didn't feel comfortable advancing the catheter due to concerns about not being able to remove the guidewire.They managed to get the guidewire to come off the catheter's end, but with a lot of resistance.The customer retrieved a new icy kit and successfully completed the insertion.No consequences or impacts on the patient.
Additional Manufacturer Narrative
Sections d1 (brand name) and d4 (catalog # and primary unique device identifier (udi) #) were corrected.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER 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: 22293879
• Report Number: 3010617000-2025-00416
• Device Sequence Number: 8921814
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 04/30/2025
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 196374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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