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	11/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll has not yet received the catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The quattro catheter (lot #unknown) was smoothly inserted into the patient's left femoral vein to induce hypothermia following cardiac arrest.The patient's initial body temperature at the start of treatment was 36 °c.The target temperature was set at 34 °c, with the maximum cooling rate applied.During the first phase of the treatment, the 500-ml saline bag was empty, and the thermogard system generated an "air trap" alarm.The pump rotor stopped, and the console entered standby mode.There was no leakage from the start-up kit (suk), and no fluid was seen on or under the thermogard console.It was therefore suspected that the catheter leaked.An infusion of 250 milliliters of saline was suspected to have entered the patient's bloodstream.The catheter was replaced.The dwell time of the catheter was 2 to 4 hours.Afterwards, the "air trap" alarm cleared, and the treatment was continued and completed using the same thermogard console.No patient injury was reported.No consequences or impacts on the patient.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated.D4 (suspect medical device, lot # and expiration date) was updated.D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The reported complaint of suspected catheter leak was not confirmed during visual and functional testing of the returned quattro catheter (lot #208953).No issues or discrepancies were found.No leaks, damage, or device malfunctions were observed during testing.The catheter functioned as intended.During functional testing of the returned catheter, 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.No leaks 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 run on a peristaltic pump for 10 minutes at a high speed.No leaks were observed, and the catheter functioned as intended.During further functional testing, the returned catheter was connected to a known-good suk and ran on a thermogard console system, running in the max warming mode with a target temperature of 37°c for 60 minutes and running in the max cooling mode with a target temperature of 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.
Event or Problem Description
The quattro catheter (lot #208953) was smoothly inserted into the patient's left femoral vein to induce hypothermia following cardiac arrest.The patient's initial body temperature at the start of treatment was 36 °c.The target temperature was set at 34 °c, with the maximum cooling rate applied.During the first phase of the treatment, the 500-ml saline bag was empty, and the thermogard system generated an "air trap" alarm.The pump rotor stopped, and the console entered standby mode.There was no leakage from the start-up kit (suk), and no fluid was seen on or under the thermogard console.It was therefore suspected that the catheter leaked.An infusion of 250 milliliters of saline was suspected to have entered the patient's bloodstream.The catheter was replaced.The dwell time of the catheter was 2 to 4 hours.Afterwards, the "air trap" alarm cleared, and the treatment was continued and completed using the same thermogard console.No patient injury was reported.No consequences or impacts on the patient.

• 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: 23833948
• Report Number: 3010617000-2025-00873
• Device Sequence Number: 5093550
• 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): 01/23/2026

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: IC-4593AE
• Device Catalogue Number: 8700-0783-40
• Device Lot Number: 208953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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: Male
• Patient Weight: 90 KG