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

Model Number	SL-2593
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	01/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted zoll tech line to report a hole discovered in the distal port of a solex 7 catheter (lot # 199265), which was inserted in the patient's right internal jugular vein.The caller stated the hole was found after noticing there was blood coming out of the line attached to the distal port and that the hole was visible.It is unknown how long after the treatment began, the issue was discovered.There was no report of an "air trap" alarm.Zoll tech line walked the caller through the safe removal of the catheter.The catheter was replaced and treatment continued.There were no issues with the thermogard console used during the event.No consequences or impacts on the patient.
Additional Manufacturer Narrative
The reported complaint of a hole in the distal port of the solex 7 catheter (lot # 199265) was confirmed during the functional and visual inspection of the returned solex 7 catheter.During the functional lumen flushing, a leak was observed from the distal luer tubing, located 1.5 cm from the proximal end of the manifold.The leak was caused by a small sharp cut (hole) in the distal luer tubing.It is likely that a suture needle or another sharp tool, such as a scalpel, accidentally cut the lumen tubing, which is attributed to user error.Functional testing was performed on the returned catheter.All infusion ports and lumens were flushed without resistance, except for the distal luer port, which was clogged with blood.During the flushing of the distal luer tubing, a leak was observed 1.5 cm from the proximal end of the manifold.Inspecting the catheter under a microscope revealed a very small, sharp cut on the distal luer tubing, 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 investigation results related to the reported complaint, and there was no previous history of complaints reported for the solex 7 catheter with lot number 199265.

• Brand Name: SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER PRIMUM KIT CUSTOM LUER APPLAUSE HEP
• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 21329575
• Report Number: 3010617000-2025-00074
• Device Sequence Number: 12742052
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081936
• 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): 02/06/2025

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: 06/30/2025
• Device Model Number: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 199265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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