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 Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
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 right femoral vein to cool the patient after cardiac arrest.The patient's body temperature at the start of treatment was 36.5 °c, and the target temperature was set at 34 °c, with the maximum rate of cooling applied.The customer reported that 10 minutes after insertion, it was not possible to "fill" the quattro catheter.The customer did not provide further clarification on the issue.The physician replaced the catheter, and it worked well without any problems.No patient injury was reported.
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 was confirmed during the functional testing of the returned quattro catheter.A water emission leak was observed from the in luer port during the pressure leak test.All infusion ports and lumens were flushed without resistance during functional testing of the returned catheter.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 in luer port during testing, confirming the reported complaint.During further inspection, the in luer was inspected under a microscope, and no crack or damage was seen on the in luer.Leak was observed coming from the inside of the in luer.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for investigation results related to the reported complaint, and there was no previous history of complaints for quattro catheter with lot number 208095.
Event or Problem Description
The quattro catheter (lot #208095) was smoothly inserted into the patient's right femoral vein to cool the patient after cardiac arrest.The patient's body temperature at the start of treatment was 36.5 °c, and the target temperature was set at 34 °c, with the maximum cooling rate applied.The customer reported that 10 minutes after insertion, it was not possible to "fill" the quattro catheter.The customer did not provide further clarification on the issue.The physician replaced the catheter, and it worked well without any problems.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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 22972918
• Report Number: 3010617000-2025-00598
• Device Sequence Number: 21097751
• 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): 10/03/2025

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 Model Number: IC-4593AE
• Device Catalogue Number: 8700-0783-40
• Device Lot Number: 208095
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: Unknown