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	08/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a draining saline bag was not confirmed during visual and functional testing of the returned quattro catheter (lot #192678).No issues or discrepancies were found on the catheter.No leak or malfunction was observed during testing, and the catheter functioned as intended.Visual examination of the returned catheter found no physical damage.During the functional pressure leak test of the returned catheter, all infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi, and no issues were found.The balloons did not leak during testing.In addition, the returned catheter was connected to a known- good suk and ran on a peristaltic pump for 10 minutes at a high-speed rate.No leak was observed, and the catheter functioned as intended.During further functional testing, the returned catheter was connected to a known-good suk and ran on the thermogard console system, running in the max warming mode with a target temperature at 37°c for 60 minutes and running in the max cooling mode with a target temperature at 35°c for 60 minutes.No leak was observed on the catheter.The balloons were properly warming during the warming mode and cooling during the cooling mode.The red pinwheel of the suk was spinning as normal.No problem was found, and the catheter functioned as intended.
Event or Problem Description
A quattro catheter (lot #192678) was utilized to provide ivtm therapy for a post-cardiac arrest patient.Although the customer did not specify the insertion site, the catheter insertion was smooth.The customer reported that during the normothermia phase of the treatment, saline was draining out of the 500-ml saline bag, which is supposed to be a closed system.The thermogard system had not triggered any alarms.Zoll ivtm territory manager assisted the customer in troubleshooting where saline could be going and if there was a breach in the balloons.The decision was made to stop therapy, remove the catheter, and switch to artic sun for cooling.No further information was provided.There was no harm to the patient.

• 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: 20257880
• Report Number: 3010617000-2024-00768
• Device Sequence Number: 7934597
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/19/2024

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: 08/31/2024
• Device Model Number: IC-4593
• Device Catalogue Number: 8700-0783-01
• Device Lot Number: 192678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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 Sex: Unknown