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

Model Number	IC-4593AE
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	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The quattro catheter (lot#: 209655) was smoothly inserted into the patient's right femoral vein to induce hypothermia.Approximately 20 hours into treatment, during the cooling phase, the thermogard system generated an "air trap" alarm.The 500-ml saline bag was found to be empty.There was no fluid on the floor, the patient's bed, or the console.The quattro catheter was removed.The customer reported observing a damaged balloon and suspected that approximately 200 ml of saline may have infused into the patient's bloodstream.The catheter was replaced, and treatment continued and completed using the same thermogard console.No patient injury occurred, and the patient remained alive and stable.
Additional Manufacturer Narrative
The reported complaint of a suspected catheter leak with a damaged balloon was not confirmed during visual and functional testing of the returned quattro catheter.No issues or discrepancies were found.No leak, damage, or device malfunction was observed during testing, and the catheter functioned as intended.During functional testing of the returned catheter, all infusion ports and lumens were flushed without resistance, except for the medial luer port, which was clogged with blood in the tubing.During the 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 or issues were found on the catheter.The balloon did not leak during testing.In addition, the returned catheter was connected to a known-good start-up kit (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 additional functional testing, the returned catheter was connected to a known-good suk and ran on the thermogard console system.The system was run in max warming mode at a target temperature of 37 °c for 60 minutes, followed by max cooling mode at a target temperature of 35 °c for 60 minutes.No leaks were observed during testing.The balloon functioned appropriately, warming during the warming mode and cooling during the cooling mode.The suk red pinwheel rotated normally.No issues were identified, and the catheter performed as intended.
Additional Manufacturer Narrative
Section a.Patient information was updated.

• Brand Name: QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN E
• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 24974070
• Report Number: 3010617000-2026-00263
• Device Sequence Number: 21446525
• Product Code: NCX
• UDI-Device Identifier: 00849111075275
• UDI-Public: 00849111075275
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0783-40
• Device Lot Number: 209655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 70 KG