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	Insufficient Information (4580)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The quattro catheter (lot # unknown) was smoothly inserted into the patient's right femoral vein under fluoroscopy in the cath lab for ivtm therapy.During the maintenance phase of the treatment within 48 hours of keeping the patient normothermic at 36 °c, the thermogard hq console generated an air trap alarm.The customer noticed that the 500-ml saline bag was dry.The customer performed a catheter leak check, and there was no leakage seen from within the insertion site, and nothing was seen externally.When the customer proceeded to change to the second saline bag, they also replaced the thermogard hq console.Two hours after resuming the treatment, the second saline bag depleted from 500 ml to 50 ml.The customer noticed the saline bag depletion before the second thermogard hq console displayed any alarm.The customer removed the catheter and discontinued the ivtm therapy.The customer suspected 850 milliliters of saline infusion into the patient's bloodstream.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
Zoll has not yet received the catheter in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.Administration of sterile cold saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals and should not harm a patient.The fluid that ran into the patient's vasculature is an anticipated event.Based on available information, no patient effect was reported.The fluid that ran into the patient's vasculature is causally related to the device and procedure.

• 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: 20884009
• Report Number: 3010617000-2024-00980
• Device Sequence Number: 12930547
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/09/2024

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 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: 11/20/2024
• Initial Report FDA Received Date: 12/09/2024
• 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