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	06/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak from the cool line catheter (lot 214575) was confirmed during functional testing.A pinhole leak was observed from the proximal end of 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 the balloons and 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 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 214575.
Event or Problem Description
On (b)(6) 2026, during ivtm therapy using the cool line catheter (lot 214575), there was backflow of blood.Therefore, the customer determined that the catheter balloon had damaged, causing a saline leak.The catheter had been smoothly inserted on the first attempt.The dwell time of the catheter was 10-20 minutes.Since there were no products in stock at the hospital, the treatment was switched to medication.No device malfunction was reported for the suk.No blood was observed in the tubing of the 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: 25685223
• Report Number: 3010617000-2026-00398
• Device Sequence Number: 9731092
• 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): 07/01/2026

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 Model Number: CL-2295
• Device Lot Number: 214575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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