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	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the quattro catheter in the 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 customer reported leakage of saline into the injection channel.There is a suspected leak of the quattro catheter (lot 198225), causing leakage of saline into the patient's blood.The 500 ml saline bag was empty.The catheter was removed and not replaced.The issue was noticed during the first hours of therapy.No consequence to 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 22851819
• Report Number: 3010617000-2025-00555
• Device Sequence Number: 19955347
• Product Code: NCX
• UDI-Device Identifier: 00849111075275
• UDI-Public: 00849111075275
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 08/20/2025

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: 198225
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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