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	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was placed into controlled hypothermia by ivtm therapy after cardiac arrest.The icy catheter (lot # 209463) was smoothly inserted into the patient's right femoral vein in a single insertion attempt.No adjunctive temperature management or relative procedures were performed on the patient prior to the ivtm therapy.The patient's initial body temperature was 36.5°c, with a target temperature of 34°c set at the max cooling rate.Approximately 25 minutes later, staff observed no flow in the cooling circuit.Manual flushing attempts were unsuccessful.The catheter was removed and replaced with another icy (lot # 209463) in the same insertion site.The removed catheter was flushed again, but still without success.About 30 minutes after using the second icy catheter, the thermogard system generated an "air trap" alarm.No fluid was visible in the bed.A catheter leak check according to zoll ifu revealed a catheter leak.The amount of saline infused into the patient's bloodstream remains unknown.The second catheter was then removed and replaced with a solex 7 catheter.No patient injury was reported.No consequences or impacts on the patient.During the call with the zoll tech line on(b)(6) the customer successfully flushed the first icy catheter.
Additional Manufacturer Narrative
Zoll did not receive the catheter in complaint for investigation.A follow-up report will be filed if and when the product is returned and an investigation has been completed.
Additional Manufacturer Narrative
The reported complaint of a catheter leak was confirmed during the functional testing of the returned icy catheter (lot # 209463).During the lumen crosstalk test, a water emission/leak was observed from the in luer port.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.All infusion ports and lumens were flushed without resistance during functional testing of the returned catheter.During the functional pressure leak test, the catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi; no leak was detected from the catheter balloons.However, a water emission/leak was observed from the in luer port during the lumen crosstalk test, 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 investigation results related to the reported complaint, and there was no previous history of complaints for the icy catheter with lot number 196563.
Additional Manufacturer Narrative
The reported complaint of a catheter leak was confirmed during the functional testing of the returned icy catheter (lot # 209463).A water emission, leak was observed from the in luer port during the pressure leak test.All infusion ports and lumens were flushed without resistance during functional testing of the returned catheter.During the functional pressure leak test, the catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi; no leak was detected from the catheter balloons.However, a water emission/leak was observed from the in luer port during testing, confirming the reported complaint.During further inspection the in luer under microscope, no crack or damage was seen on the in luer.Leak was observed coming from the inside of the in luer.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 investigation results related to the reported complaint, and there was no previous history of complaints for the icy catheter with lot number 196563.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 21946158
• Report Number: 3010617000-2025-00321
• Device Sequence Number: 21112691
• Product Code: NCX
• UDI-Device Identifier: 00849111075251
• UDI-Public: 00849111075251
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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 Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 209463
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 05/22/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/21/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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