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	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak from cool line catheter (lot 204870) was confirmed during functional testing.A pinhole leak was observed from the proximal the distal balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.Visual inspection of the returned catheter was performed.No physical damage was observed on the catheter.Blood residue was observed in luered tubings.Functional leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi.Upon pressurizing the catheter, a pinhole leak was observed from the distal balloon (2 cm away from proximal end of distal balloon), confirming the reported complaint.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 204870.
Event or Problem Description
On (b)(6) 2025, ivtm therapy using a cool line catheter (lot 204870) was initiated.At around 4:00 am on (b)(6) 2025, a nurse reported to the clinical engineer that the thermogard hq console generated an air trap alarm.Therapy was discontinued.The alarm on the console was cleared and the console is functioning as intended.The dwell time of the catheter was about 6 days.On (b)(6) 2025, azm sales rep.Contacted the physician and confirmed that a cool line catheter had been used and that the balloon was suspected to have been damaged.No patient injuries were reported.

• 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: 23763911
• Report Number: 3010617000-2025-00853
• Device Sequence Number: 21375059
• 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): 12/09/2025

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: 05/04/2026
• Device Model Number: CL-2295
• Device Lot Number: 204870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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