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 Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The solex 7 catheter associated with this complaint was not returned for evaluation.A supplemental report will be filed when the product is returned, and investigation has been completed.
Event or Problem Description
During the removal of a solex 7 catheter (lot# unknown), four days after the catheter placement, the balloon appeared to have damage.The bedside nurse initially attempted removal but encountered resistance and sought assistance from the attending physician.Although the physician successfully removed the catheter, the resistance was greater than expected.Per the reporter, the catheter deflation before the removal was done using the recommended procedure.Examination of the solex balloon revealed a section stripped from the catheter shaft and severed from the rest of the balloon.Per the reporter, the solex catheter was the patient's only invasive line, with no other foreign bodies present (e.G., pacemakers, icds, ivc filters).The resistance and resulting balloon damage appeared to be consistent with normal vasculature.Additionally, there were no issues during the insertion of this catheter, and cooling and warming therapy proceeded without complications.No surgical intervention was required and no adverse effects on the patient were observed.
Event or Problem Description
During the removal of a solex 7 catheter (lot# 198213), four days after the catheter placement, the balloon appeared to have damage.The bedside nurse initially attempted removal but encountered resistance and sought assistance from the attending physician.Although the physician successfully removed the catheter, the resistance was greater than expected.Per the reporeter, the catheter deflation before the removal was done using the recommended procedure.Examination of the solex balloon revealed a section stripped from the catheter shaft and severed from the rest of the balloon.Per the reporter, the solex catheter was the patient's only invasive line, with no other foreign bodies present (e.G., pacemakers, icds, ivc filters).The resistance and resulting balloon damage appeared to be consistent with normal vasculature.Additionally, there were no issues during the insertion of this catheter, and cooling and warming therapy proceeded without complications.No surgical intervention was required and no adverse effects on the patient were observed.
Additional Manufacturer Narrative
The reported complaint of the physician experienced a greater than expected resistance when the catheter was removed and the solex balloon revealed a section stripped from the catheter shaft was confirmed during the visual inspection of the returned solex 7 catheter (lot # 198213).As received, the catheter serpentine balloon was completely damaged.The middle of the serpentine balloon was torn, and detached from the catheter balloon shaft.The probable root cause could be due to a handling issue during the initial attempt to remove the catheter.Visual inspection of the returned catheter was performed and the serpentine balloon was noted completely damaged.The middle of the serpentine balloon (loop 2nd, 3rd, 4th, and 5th) was completely torn, and detached from the catheter balloon shaft.No kink was observed on the catheter.In addition, the blood residue was observed on the catheter's serpentine balloon.During functional testing, all infusion ports and extension tubes were flushed without resistance except for the in/out luer ports.The in/out luer lumens are unable to flush due to the damage to the balloon.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 previous history of complaints reported for the solex 7 catheter with lot number 198213.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 21500921
• Report Number: 3010617000-2025-00160
• Device Sequence Number: 4500928
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 198213
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/02/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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