MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN, FINAL PKGED KIT NE; 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	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a suspected cool line catheter (lot # 195818) leak was confirmed during functional testing.A pinhole leak was observed at the proximal end of the distal balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.During the functional pressure leak test all infusion ports and lumens were flushed without resistance.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 pinhole leak was observed 1 cm away from the proximal end of the distal 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 history of previous complaints reported for the cool line catheter lot number 195818.
Event or Problem Description
As reported, during the ivtm treatment for the trauma patient, the customer noticed the solution in the saline bag had decreased.The physician performed the cool line catheter (lot # 195818) check and the catheter leak was suspected.No further details were provided.No consequences or impact to the patient.

• Brand Name: COOL LINE® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT JAPAN, FINAL PKGED KIT NE
• 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
• MDR Report Key: 20501260
• Report Number: 3010617000-2024-00836
• Device Sequence Number: 12669995
• Product Code: NCX
• UDI-Device Identifier: 00849111075176
• UDI-Public: 00849111075176
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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 Expiration Date: 06/21/2025
• Device Model Number: CL-2295
• Device Lot Number: 195818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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