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); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the cool line catheter in the 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
On (b)(6) 2025, ivtm therapy using cool line catheter (lot 206444) for a head trauma patient began.On (b)(6) 2025, it was reported that the saline in the saline bag had emptied.This was confirmed by the medical doctor.In addition, as it was time to end temperature management, the catheter was removed, and temperature management was terminated.Saline infusion of about 200-300 ml into the patient was suspected.The dwell time of the catheter was about 5 days.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of a leak from cool line catheter (lot 206444) was confirmed during functional testing.A leak was observed from the middle of the proximal balloon, due to a tear in the balloon.The probable root cause of the reported complaint was a latent material defect.Visual inspection of the returned catheter was performed, and no physical damage was observed on the catheter.Blood residue was observed in the balloons and luered tubings.During functional testing, all infusion ports and lumens were flushed without resistance.Upon flushing the in/out lumens, a leak was observed from the middle of the proximal balloon.Further inspection of the catheter under the microscope revealed a tear in the balloon, located at the middle of the proximal 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 information related to the reported complaint, and there was no previous history of complaints reported for the cool line catheter with lot number 206444.

• 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: 22918760
• Report Number: 3010617000-2025-00585
• Device Sequence Number: 9783632
• 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): 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): 09/23/2025

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: 05/09/2026
• Device Model Number: CL-2295
• Device Lot Number: 206444
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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