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	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter in the complaint was returned to zoll on (b)(6) 2025 for evaluation.However, the investigation is still in progress.A follow-up report will be submitted when the investigation is completed.
Event or Problem Description
The solex 7 catheter (lot # 204764) was inserted into the patient's right jugular vein to initiate ivtm therapy to induce therapeutic hypothermia.The catheter remained in place without issues for seven days but needed to be replaced to continue treatment due to the patient's persistent fever.First, another solex 7 catheter (lot # 204764) was successfully inserted into the patient's left jugular vein, opposite the initial site.Both the guidewire and the second catheter advanced smoothly.After placing the second catheter, the customer attempted to remove the first solex 7 catheter.The removal was significantly difficult as the catheter's balloon was partially detached and torn at one location.Notably, similar tears were observed on both sides of the catheter.It appeared that the balloons of the two catheters may have become entangled or hooked together, causing the first catheter's balloon to detach from the shaft during removal.It was confirmed that the customer used a syringe to remove saline from the catheter balloon before removing the catheter.The (out) luer of the catheters was clamped before the vacuum from the syringe was applied to the (in) luer.Additionally, the balloons were deflated with a syringe before removal.The customer ensured that the first solex 7 catheter and its entire balloon were removed without any surgical intervention.X-ray and ultrasound were used during and after the catheter removal.The customer also removed the second solex 7 catheter because of a kink that formed in the catheter, rendering the infusion lumen unusable.Removal of the second catheter was smooth and caused no issues, with a dwell time of one hour.Subsequently, a quattro catheter was inserted into the femoral vein, and therapy was resumed.No patient injury was reported, and the patient remained ventilated and stable.The zoll senior territory manager advised the customer that catheter replacement should have begun with the insertion of a femoral catheter to maintain medication delivery, followed by removal of the first catheter, instead of having two solex 7 catheters in place simultaneously.
Additional Manufacturer Narrative
Sections d4 (expiration date) and h4 (device manufacture date) were updated.The reported complaint of difficulty in removing the catheter was confirmed during the visual inspection.The returned catheter exhibited complete damage to the serpentine balloon, with its loop being torn and detached from its midsection.The observed damage is likely attributable to user handling during catheter removal.A visual inspection of the returned catheter revealed significant damage to the serpentine balloon.The balloon was completely damaged, with loops 3 through 7 torn and detached from the serpentine balloon shaft.No kinks were observed on the catheter.During functional testing, all infusion ports and lumens were flushed without resistance except for the in and out luer ports.These lumens could not be flushed due to the extensive balloon damage.Further functional testing could not be performed due to the condition in which the catheter was returned.Historical complaints were reviewed for investigation results related to the reported complaint, and there was no similar history of complaints reported for the solex 7 catheter with lot number 204764.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 23373429
• Report Number: 3010617000-2025-00741
• Device Sequence Number: 18360422
• 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): 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): 11/19/2025

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: 08/05/2026
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 204764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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 Age: 20 YR
• Patient Sex: Female