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	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak from the cool line catheter (lot 196904) was confirmed during functional testing.During the in/out lumen flushing, a leak was observed from the proximal end of the distal 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.Functional testing was the returned catheter performed.All infusion ports and lumen were flushed without resistance.During the in/out lumen flushing, a leak from the distal balloon was observed, located at 1.5 cm away from the proximal end of the distal balloon, confirming the reported complaint.The returned cool line catheter was inspected under a microscope and a very small tear on the distal balloon was observed.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 were no similar complaints reported for the cool line catheter with lot number 196904.
Event or Problem Description
Ivtm therapy using the cool line catheter (lot 196904) was started.Approximately two hours after the start, the air trap alarm on the thermogard xp ivtm system sounded, and blood was observed flowing into the saline bag.Since the patient's condition was stable, the use of thermogard was discontinued.The alarm on the console was cleared.No device malfunction is suspected for the start-up kit (suk).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: 21590099
• Report Number: 3010617000-2025-00179
• Device Sequence Number: 18400935
• 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): 03/12/2025

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: 10/09/2025
• Device Model Number: CL-2295
• Device Lot Number: 196904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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