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	Swelling/ Edema (4577)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 77-year-old male patient weighing 90 kg was receiving ivtm therapy for post-cpr hypothermia using a solex 7 catheter (lot #214144).The catheter was inserted into the patient's right internal jugular vein with a smooth, single-attempt insertion.It was positioned at 16 cm.Norepinephrine was infused through the catheter's infusion lumen.After 24 hours, the patient exhibited significant fluctuations in catecholamine levels without any change in flow rate.Over time, it was observed that the catheter insertion site on the neck was slightly swollen, and the swelling continued to worsen.The customer noted leaked fluid at the puncture site.According to the customer, it cannot be confirmed whether the leaked fluid was medication; however, this is assumed due to the blood pressure fluctuations.There was also suspicion of a saline leak, but a reduction in saline solution was not confirmed.The swollen area was cooled locally to reduce swelling.No imaging was performed to verify the catheter's correct position, and the patient was not moved or transported before the issue was reported.The patient's temperature at the start of ivtm therapy was 35.6°c, with a target of 36°c at the maximum rate, and at the time of the issue, it was 36.1°c.The catheter was then removed and replaced with a standard central venous catheter.The patient's current condition is stable.
Additional Manufacturer Narrative
Zoll has not received the solex 7 catheter for investigation.A follow-up or final report will be submitted when the product is returned and the investigation has been completed.The event of swelling at the insertion site was assessed as not serious because it does not meet the criteria for seriousness.The swollen area was cooled locally to reduce swelling.Based on available information, the event was related to the zoll catheter due to relevant timing and location.More likely, the medication leaked and caused slight swelling on the neck at the catheter insertion site.The event of swelling at the insertion site was causal related to the device and procedure.
Additional Manufacturer Narrative
The customer's complaint of catheter leak was not confirmed during visual and functional testing of the returned solex 7 catheter (lot #214144).No leaks, damage, or device malfunctions were observed during testing, and the catheter functioned as intended.Functional testing of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device, and the balloon was fully inflated to 100 psi; no leaks or issues were found on the catheter.The balloon did not leak during testing.In addition, the returned catheter was connected to a known-good suk and ran on a peristaltic pump for 10 minutes at a flow rate of 240 ml/min.No leak was found, and the catheter functioned as intended.During further functional testing, the returned catheter was connected to a known-good suk and operated on the thermogard console system, running in the max warming mode with a target temperature of 37°c for 60 minutes and in the max cooling mode with a target temperature of 35°c for 60 minutes.No leak was observed on the catheter.The balloon was properly warming during the warming mode and cooling during the cooling mode.The red pinwheel of the suk was spinning as normal.No problem was found, and the catheter functioned as intended.An additional guidewire test was performed: a known-good zoll guidewire was slowly inserted through the catheter's central lumen, starting at the catheter tip, and exited through the distal infusion luer port without resistance.The guidewire could be passed through the entire length of the lumen with no resistance.The event of swelling at the insertion site was assessed as not serious because it does not meet the criteria for seriousness.Based on available information, the event was related to the zoll catheter due to relevant timing and location.More likely, the medication leaked and caused slight swelling on the neck at the catheter insertion site.The swollen area was cooled locally to reduce swelling.Based on the evaluation, the catheter was confirmed to have performed as intended.It is therefore considered possible that the reported medication leak was associated with the catheter insertion technique.The event of swelling at the insertion site has been reassessed and is considered possibly related to the device and the device insertion procedure.

• 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 ; 4084192347
• MDR Report Key: 24941578
• Report Number: 3010617000-2026-00240
• Device Sequence Number: 18374323
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 214144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 90 KG