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

Model Number	CL-2295
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	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the icy catheter for investigation.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
An icy catheter was used on a 70-year-old male patient as part of a cooling procedure involving the thermogard hq system.During use, on day 2, a leak from the catheter balloon was observed.As a result, approximately 300 ml of normal saline got leaked and infused into the patient's circulation.Another catheter was used to continue the therapy.No adverse effects or injuries to the patient were reported.
Additional Manufacturer Narrative
Additional information in d4 (lot # and expiration date) and h4 (device manufacture date).The reported complaint of catheter leak was confirmed during the functional testing of the returned icy catheter (lot #208436).A bonding leak was observed at the distal end of the medial balloon during the functional pressure leak test.The probable root cause could be a latent defect in the bond.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.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 #208436.

• Brand Name: COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT 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: 22983084
• Report Number: 3010617000-2025-00599
• Device Sequence Number: 13148902
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 09/30/2025

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: CL-2295
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: 208436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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 Age: 70 YR
• Patient Sex: Male