MAUDE Adverse Event Report: ZOLL CIRCULATION ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE (HEPARIN); INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER

Model Number	IC-3893
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician inserted the catheter (lot# unknown) into the patient's femoral vein during the ivtm therapy.Per the reporter, the placement was difficult as providers struggled with placing the line initially.The customer noticed that the red flow indicator on the start-up kit (suk) (lot# unknown) was not rotating and the patient was not cooling to the target temperature.The suk was tested on the close loop and the red flow indicator was spinning, confirming a normal flow.The customer was unable to flush the catheter over the in and out luers when used with the syringe filled with saline.The customer was advised to replace the catheter and utilize the blanket surface system to reduce the patient's temperature from 37.6°c to 37°c until a decision is made regarding the catheter replacement.The patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
The 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.The catheter model and lot # is unknown.
Additional Manufacturer Narrative
The reported complaint of the patient not cooling was not confirmed during the functional testing of the returned icy catheter (lot# 192970).No issues or discrepancies were found.No leak and no device malfunction was observed during testing, and the catheter functioned as intended.Visual inspection of the returned catheter was performed.There was no kink or physical damage observed on the catheter.Blood residues were observed on the balloons and in luered tubings.A functional pressure leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance, except the medial luered tubing due to blood clogging.The catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi; no leaks or issues were found.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.The suk red pinwheel rotated normally, 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.The balloons were properly warming during the warming mode and cooling during the cooling mode.No leak or damage was found on the catheter.The suk red pinwheel and the pump roller were rotating normally, and saline flow was observed during testing.The catheter functioned as intended.
Event or Problem Description
A physician inserted the icy catheter (lot# 192970) into the patient's femoral vein during the ivtm therapy.Per the reporter, the placement was difficult as providers struggled with placing the line initially.The customer noticed that the red flow indicator on the start-up kit (suk) (lot# unknown) was not rotating and the patient was not cooling to the target temperature.The suk was tested on the close loop and the red flow indicator was spinning, confirming a normal flow.The customer was unable to flush the catheter over the in and out luers when used with the syringe filled with saline.The customer was advised to replace the catheter and utilize the blanket surface system to reduce the patient's temperature from 37.6°c to 37°c until a decision is made regarding the catheter replacement.The patient's status information was requested but the customer did not provide a response.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE (HEPARIN)
• Common Device Name: INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19494661
• Report Number: 3010617000-2024-00451
• Device Sequence Number: 15578553
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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-3893
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: 192970
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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