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

Model Number	IC-3893AE
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	04/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The icy catheter associated with this complaint was not returned for evaluation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
Ivtm therapy started using an icy catheter (lot # unknown).The catheter was placed into the left femoral vein smoothly on the first attempt.Per the reporter, surface warming bags were used on the patient as a temperature management method before ivtm therapy.After four days of therapy, the 500 ml saline bag was noted empty within six hours.After inspecting the catheter and the suk for leaks, the first bag was replaced; however, the saline level in the second bag started decreasing within two hours.The customer estimated that between 600 and 700 ml of saline solution had been infused into the patient's bloodstream.There were no system alarms noted during the treatment and the console was confirmed to be functional.The catheter was not replaced and the thermogard console was stopped.The patient was reported to be in a difficult condition, but there was no injury or death reported.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of catheter leak was confirmed during functional testing of the returned icy catheter (lot#: 194378).During the functional pressure leak test, a bonding leak was observed at the distal end of the medial balloon of the catheter.The probable root cause of the reported complaint could be a latent defect in the bond.During functional testing, all infusion ports and lumens were flushed without resistance.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 bonding leak was observed at the distal end of the medial 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 previous history of complaint reported for the icy catheter with lot#: 194378.Additional information: b5 and d4, lo # for catheter was updated.
Event or Problem Description
Ivtm therapy started using an icy catheter (lot#: 194378).The catheter was placed into the left femoral vein smoothly on the first attempt.Per the reporter, surface warming bags were used on the patient as a temperature management method before ivtm therapy.After four days of therapy, the 500 ml saline bag was noted empty within six hours.After inspecting the catheter and the suk for leaks, the first bag was replaced; however, the saline level in the second bag started decreasing within two hours.The customer estimated that between 600 and 700 ml of saline solution had been infused into the patient's bloodstream.There were no system alarms noted during the treatment and the console was confirmed to be functional.The catheter was not replaced and the thermogard console was stopped.The patient was reported to be in a difficult condition, but there was no injury or death reported.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (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: 21958784
• Report Number: 3010617000-2025-00330
• Device Sequence Number: 9197500
• Product Code: NCX
• UDI-Device Identifier: 00849111075251
• UDI-Public: 00849111075251
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 08/18/2025
• Device Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 194378
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Weight: 60 KG