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	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak in the quattro catheter (lot 198059) was confirmed during the functional testing of the catheter.A water emission, leak was observed from the proximal luer port and at the proximal infusion lumen opening during the lumen crosstalk test.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.Visual inspection of the returned catheter was performed.No physical damage was observed on the catheter.Blood residue was observed on the balloons and in luered tubings.Functional testing of the returned catheter was performed.All the infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi, no leak was observed from the catheter balloons.However, a water emission, leak was observed from the proximal luer port and at the proximal infusion lumen opening during the lumen crosstalk test, confirming the reported complaint.Historical complaints were reviewed for investigation related to the reported complaint, and no similar complaint was reported for quattro catheter with lot # 198059.
Event or Problem Description
A 70-year-old male patient (90 kg) received ivtm therapy following cpr and ventricular fibrillation.The quattro catheter (lot # 198059) was successfully inserted into the patient's right femoral vein on the first attempt.The patient's temperature at the start of therapy was 36°c, with a target temperature of 34°c at the max rate.During treatment, the saline bag was found empty, triggering an air trap alarm on the console.Inspection per instructions for use (ifu) identified a leak at the proximal infusion opening of the catheter.Subsequently, a replacement quattro catheter (lot # 198059) was used; however, another saline decrease occurred after an unspecified period, again revealing a leak at the proximal infusion site upon inspection.Per the reporter, the infusion of 500 ml into the patient's bloodstream was suspected.Per the reporter, the console was determined to be functional.Following two unsuccessful attempts, the physician determined to discontinue temperature management for the patient.No further details were provided if an alternative temperature management therapy was utilized.The patient is stable, and no patient injury was reported.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 21301742
• Report Number: 3010617000-2025-00086
• Device Sequence Number: 15665729
• Product Code: NCX
• UDI-Device Identifier: 00849111075275
• UDI-Public: 00849111075275
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/04/2025

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: 04/10/2025
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0783-40
• Device Lot Number: 198059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG