MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. ZOLL IVTM SOLEX 7 CATHETER; 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	01/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, at approximately 18:00, a solex catheter (lot # 209953) was successfully inserted into the right internal jugular vein on the first attempt with no complications.Hypothermia therapy was initiated and continued until (b)(6) 2026.At approximately 10:00 on (b)(6) an air trap alarm was triggered.Upon inspection, the nurse observed that the saline in both the catheter and the start-up kit (suk) tubing had turned pink.While the 500 ml saline bag was in use, the physician suspected a balloon rupture and estimated that 200 cc or less of saline had been infused into the patient's bloodstream.Because blood was visible in the saline loop, the physician opted not to perform a manual leak check per the ifu and immediately replaced the catheter and suk.The thermogard console remained in use and was found to be fully functional, as treatment continued without further interruption once the disposables were replaced.There were no reported issues with the suk itself, and no patient injury occurred.
Additional Manufacturer Narrative
The solex 7 catheter involved in the reported complaint 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.
Additional Manufacturer Narrative
The reported complaint of a leak from the solex 7 catheter (lot # 209953) was confirmed during functional testing.A pinhole leak was observed in the middle of the serpentine balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.A functional leak test of the returned catheter was performed, and all infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device during the functional pressure leak test.Upon pressurizing the catheter up to 100 psi, a pinhole leak was observed in the middle of the serpentine balloon, thus 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 following process.Historical complaints were reviewed for information related to the reported complaint, and there was no previous history of complaints reported for the solex catheter with lot number 209953.

• Brand Name: ZOLL IVTM SOLEX 7 CATHETER
• 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: 24447456
• Report Number: 3010617000-2026-00114
• Device Sequence Number: 10301096
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081936
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 209953
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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
• Patient Sex: Unknown