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 Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
The customer experienced difficulty priming a new saline bag, suspecting improper spiking of the previous bag that resulted in volume loss.After reconnecting the start-up kit (suk) tubing properly and restarting the thermogard console, therapy resumed.However, later in the day, the customer reported a suspected fluid loss in the 1-liter saline bag.The volume of saline to have entered the patient's bloodstream is unknown.Per the reporter, the quattro catheter (lot# unknown) was placed in the right femoral vein with an arterial line at the same site.The customer was advised that it appeared to be a leak in the catheter and requested to replace the catheter.The patient reached the target temperature and was in the maintenance phase.The catheter was successfully replaced, patient therapy was completed, and the patient was re-warmed without any further incident.No consequences or impact to the patient.
Event or Problem Description
The customer experienced difficulty priming a new saline bag, suspecting improper spiking of the previous bag that resulted in volume loss.After reconnecting the start-up kit (suk) tubing properly and restarting the thermogard console, therapy resumed.However, later in the day, the customer reported a suspected fluid loss in the 1-liter saline bag.The volume of saline to have entered the patient's bloodstream is unknown.Per the reporter, the quattro catheter (lot# 205587) was placed in the right femoral vein with an arterial line at the same site.The customer was advised that it appeared to be a leak in the catheter and requested to replace the catheter.The patient reached the target temperature and was in the maintenance phase.The catheter was successfully replaced, patient therapy was completed, and the patient was re-warmed without any further incident.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of the quattro catheter (lot# 205587) leak was confirmed during functional testing.A pinhole leak was observed at the distal end of the medial 1 balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.During the functional pressure leak test all infusion ports and lumens were flushed without resistance, except the distal and proximal luer ports due to a blood clog inside the tubing.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.Upon pressurizing the catheter, a pinhole leak was observed at the distal end of the medial 1 balloon, confirming the reported complaint.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 information related to the reported complaint, and there was no history of previous complaints reported for the quattro catheter lot number 205587.Additional information: b5 and d4, lot # for catheter was updated.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 21870226
• Report Number: 3010617000-2025-00275
• Device Sequence Number: 14455286
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 11/30/2025
• Device Model Number: IC-4593
• Device Catalogue Number: 8700-0783-01
• Device Lot Number: 205587
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/20/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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