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

Model Number	IC-3893
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	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint that the saline line was pink-tinged was confirmed during functional testing of the returned icy catheter (lot #202542).During the functional pressure leak test, a bonding leak was observed at the proximal end of the medial balloon.The probable root cause of the bonding leak could be a latent defect in the bond.Also, a leak from the in-lumen tubing was observed during testing.A small sharp cut on the lumen was noted.The root cause of the sharp cut was not conclusively determined.However, sharp tools like a scalpel may have accidentally cut the catheter lumen tubing.A functional leak test of the returned catheter was performed.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 proximal end of the medial balloon, and a leak from the in-lumen tubing was observed during testing, confirming the reported complaint.When observing the in-lumen tubing leak under the microscope, a tiny sharp cut on the lumen was noted 3mm away from the distal end of the in luer.The sharp cut caused the leak from the lumen tubing.It is unlikely that the defective catheter was shipped.All catheters are 100% inspected for leaks during manufacturing 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 no previous history of complaints was reported for the icy catheter with lot #202542.
Event or Problem Description
During the maintenance phase of the ivtm therapy, the nurse noticed that the saline line was pink-tinged.The ivtm therapy was stopped, notified the physician, and the first icy catheter (lot #202542) was replaced with the second icy catheter (lot #202542).During the second icy catheter use, the saline bag was noted to be depleting, and no blood tinge was noted.The catheter was removed, and cooling pads were used to continue the therapy.The nurse suspects approximately 250cc of saline infusion into the patient's bloodstream.The dwell time of the first icy catheter was 8 hours, and the second icy catheter was 6 hours.No harm to the patient was reported.

• Brand Name: ICY® 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 21203602
• Report Number: 3010617000-2025-00038
• Device Sequence Number: 8157506
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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: 10/30/2025
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 202542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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