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	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a leaking cool line catheter (lot # unknown) and the infusion of 200 ml of saline.Per the reporter, the catheter insertion was smooth, and the catheter was placed after the first attempt.The catheter leak was noted 9 days after catheter placement.No consequences or impact to the patient.
Additional Manufacturer Narrative
The zoll cool line catheter was not returned to zoll for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

• 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
• MDR Report Key: 19815055
• Report Number: 3010617000-2024-00571
• Device Sequence Number: 8683857
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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: CL-2295
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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