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

Model Number	IC-4593
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2026
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 customer contacted zoll after completing ivtm therapy on a patient and was attempting to remove the quattro catheter (lot # unknown).Before removal, they extracted residual saline from the catheter balloons but did not use the syringe provided with the catheter kit.The customer reported they were unable to remove the catheter due to resistance, although all saline had been removed from the catheter.Since the customer confirmed they had already followed zoll's instructions for use (ifu) and were still experiencing resistance, zoll tech support advised them to do an x-ray to identify the source of the resistance and call back.No further information was provided.The patient's status information was requested, but the customer did not provide a response.

• Brand Name: QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN)
• 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: 24779755
• Report Number: 3010617000-2026-00197
• Device Sequence Number: 10036968
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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-4593
• Device Catalogue Number: 8700-0783-01
• Device Lot Number: UNKNOWN
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/03/2026
• 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