MAUDE Adverse Event Report: ZOLL CIRCULATION INC COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN, FINAL PKGED KIT NE; INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER

Model Number	CL-2295
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At 11:00 a.M.On (b)(6) 2025, ivtm therapy using cool line catheter (lot 199403) began.The catheter was inserted into the left internal jugular vein.At 9:00 a.M.On 8/24/2025, the amount of saline in the saline bag was decreasing, and damage to the catheter balloon was suspected, so the medical doctor considered replacing the catheter.At 5:00 p.M.On the same day, the doctor considered surgical removal of the catheter, as he considered it difficult to remove.However, the catheter was able to be removed without any problem.Additional surgery/ surgical removal was not needed.No injury or harm to the patient.
Additional Manufacturer Narrative
The reported complaint of a leak from the cool line catheter (lot 199403) was confirmed during visual inspection.As received, the distal catheter balloon was completely damaged.A circumferential tear in the middle of distal balloon was observed.The probable root cause of catheter leak was a latent material defect.The secondary complaint of difficulty in removing the catheter was also confirmed during visual inspection.Half of the distal balloon was bunched up at the distal end of the catheter.The balloon damage likely resulted in an increase in the resistance during the removal process.Visual inspection of the returned catheter was performed and found that the distal balloon was completely damaged.A circumferential tear in the distal balloon was observed, located at the middle of distal balloon, the half broken balloon was observed to be bunched at distal end of distal balloon, confirming the reported complaint.Blood residue was observed in the balloons and luered tubing.No kinks on the catheter shaft and no other physical damage was observed.During functional testing, all infusion ports and lumens were flushed without resistance, except for the in/out luer ports.During flushing the in/out lumens, a leak was observed from the middle of the distal balloon due to the damage of the balloon, confirming the reported complaint.An additional guidewire test was performed: a known-good zoll guidewire was slowly inserted into the tip of the catheter and exited to the distal infusion luered port without resistance.The guidewire could be passed through the entire length of the lumen with no resistance.Further functional testing could not be performed due to the condition in which the catheter was returned.Historical complaints were reviewed for information related to the reported complaint, and there were no similar complaints reported for the cool line catheter with lot number 199403.

• Brand Name: COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN, FINAL PKGED KIT NE
• 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 ; 4084192922
• MDR Report Key: 23092461
• Report Number: 3010617000-2025-00673
• Device Sequence Number: 9672404
• Product Code: NCX
• UDI-Device Identifier: 00849111075176
• UDI-Public: 00849111075176
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: 11/22/2025
• Device Model Number: CL-2295
• Device Lot Number: 199403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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