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 Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of difficulty while removing the catheter was not confirmed during the visual and functional testing of the returned solex 7 catheter (lot #198495).No issues or discrepancies were found.No device malfunction was observed during the 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 balloons were fully inflated when pressurized up to 100 psi; no leak and no issues were found.The catheter functioned as intended.An additional guidewire test was performed: a known-good zoll guidewire was slowly inserted through the central lumen of the catheter, 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.
Event or Problem Description
The solex 7 catheter (lot #198495) was utilized in ivtm therapy for a burn patient.The customer reported significant difficulty while removing the catheter, noting the presence of blood clot fragments on the serpentine balloon.The customer reported they followed zoll ifu instructions to achieve a safe catheter removal by deflating the balloon with a 20-ml syringe to remove residual saline and rotating the catheter during extraction.The customer was concerned about the appearance of the catheter upon removal.Although the solex 7 catheter's serpentine balloon remained intact, the resistance encountered during removal raised concerns about potential blood vessel injury.While the patient was not harmed, the customer expressed concerns regarding the apparent blood clots on the catheter.No consequences or impacts on the patient.

• 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: 20215845
• Report Number: 3010617000-2024-00710
• Device Sequence Number: 15254585
• Product Code: NCX
• UDI-Device Identifier: 00849111075312
• UDI-Public: 00849111075312
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/13/2024

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: 02/16/2026
• Device Model Number: SL-2593AE
• Device Catalogue Number: 8700-0793-40
• Device Lot Number: 198495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/13/2024
• Date Device Manufactured: 12/27/2023
• 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 Sex: Unknown