MAUDE Adverse Event Report: ZOLL CIRCULATION, INC SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU; INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER

Model Number	SL-2593AE
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	01/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a loss of saline during ivtm therapy for a 67-year-old 85 kg male patient.A balloon leakage was suspected on the solex catheter (lot 207977).Approximately 200 ml of saline infusion into the patient was suspected.The catheter has been inserted into the left internal jugular site smoothly on the first attempt.The dwell time was 56 hours.The catheter was removed and replaced.Subsequently the saline bag was replaced, per ifu.The same console was used to continue therapy.No patient injury reported.
Additional Manufacturer Narrative
The reported complaint that a balloon leakage was suspected on the solex catheter (lot 207977) was not confirmed during the visual and functional testing.No issues or discrepancies were found.No leak, no damage, no device malfunction was observed during testing, and the catheter functioned as intended.Visual inspection of the returned catheter was performed.As returned, the guidewire was inside the catheter, and the guidewire was able to be removed from the catheter without resistance.There was no physical damage observed on the catheter.Blood residue was observed on the catheter's serpentine balloon.Functional testing of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloon was fully inflated when pressurized up to 100 psi; no leak, no issues were found on the catheter.The balloon did not leak during testing.In addition, the returned catheter was connected to a known-good suk and ran on a peristaltic pump for 10 minutes at a flow rate of 240 ml/min.No leak was found, and the catheter functioned as intended.During further functional testing, the returned catheter was connected to a known-good suk and ran on the thermogard console system, running in the max warming mode with a target temperature at 37°c for 60 minutes and running in the max cooling mode with a target temperature at 35°c for 60 minutes.No leak was observed on the catheter.The balloon was properly warming during the warming mode and cooling during the cooling mode.The red pinwheel of the suk was spinning as normal.No problem was found, and the catheter functioned as intended.

• Brand Name: SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU
• 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
• MDR Report Key: 24369291
• Report Number: 3010617000-2026-00092
• Device Sequence Number: 9781744
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K081936
• 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): 02/17/2026

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: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 207977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/25/2024
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 85 KG