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

Model Number	SL-2593AE
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	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the first attempt to insert the solex catheter (lot unknown) in the left subclavian vein of the 76-year-old, 172 cm, 51kg female patient was unsuccessful.The catheter was disposed of by the customer.No additional information is available regarding the first failed attempt to insert the catheter.During the second attempt, a new solex catheter (lot 197459) was placed according to the instructions for use (ifu), and the infusion lumens could be flushed well before insertion.The x-ray confirmed the correct positioning of the catheter.After insertion and the x-ray check, medication administration through all lumens was very irregular, with medication occasionally leaking at the insertion site.The cooling function of the catheter was not affected.The problem only affected the infusion lumens and not the cooling lumens.The dwell time was approximately 12 hours.The catheter was removed after 24 hours, and ivtm therapy was stopped.The catheter was replaced by a regular central venous catheter.No patient injury reported.
Additional Manufacturer Narrative
The reported complaint that medication administration through all lumens of the solex catheter (lot 197459) was very irregular, with medication occasionally leaking at the insertion site was confirmed during functional testing.A leak was observed from the in luer-lock connection during the pressure leak test, due to a crack in the in luer.The probable root cause could be due to a luer molding defect.Functional leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance, except the medial lumen due to blood clogged inside the tubing.During the functional pressure leak test, the catheter was connected to a pressurized inflation device.Upon pressurizing the catheter up to 100 psi, a leak was observed from the in luer-lock connection, thus, confirming the reported complaint.No leak was observed from the balloons.In addition, the catheter in luer lock connection was inspected under a microscope, and a crack in the in luer was observed.The crack in the in luer caused the leak in the catheter.Historical complaints were reviewed for information related to the reported complaint, and there were no similar complaints reported for the solex catheter with lot number 197459.

• Brand Name: SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU
• 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: 20636692
• Report Number: 3010617000-2024-00872
• Device Sequence Number: 7443200
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 01/05/2026
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 197459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 51 KG