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	Difficult to Remove (1528)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The solex 7 catheter (lot # unknown) was inserted into the right ij (internal jugular) to initiate ivtm therapy.When attempting to remove the catheter, the nurse encountered resistance.Another nurse and two intensivists also tried to remove it at the bedside.A bedside ultrasound was performed, and the physician initially suspected a clot around the catheter.Ir (interventional radiology) was consulted for removal and recommended a vascular consultation.The hospital's cardiovascular (cv) surgeon took the patient to the operating room (or).The patient was positioned for carotid surgery, and after a timeout including identification, laterality, procedure, personnel, and consent, the physician made a 3 cm incision over the catheter site.Dissection through the sternocleidomastoid muscle was performed, following the catheter.At this point, enough soft tissue had been cleared to remove the catheter.Upon removal, the balloon was found to be no longer smooth.
Additional Manufacturer Narrative
Zoll has not received the solex 7 catheter for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.Event was serious because it required surgical intervention to prevent life-threatening injury.Event of catheter removal difficulty was causal related to the device.Catheter removal difficulty is anticipated event and could potentially occur with usage of any catheter.
Additional Manufacturer Narrative
Additional information in b5 (describe event or problem), d4 (lot # and expiration date), h4 (device manufacture date), and h11 (additional manufacturer narrative).The reported complaint of difficulty removing the solex 7 catheter (lot #206677) was confirmed during visual inspection of the returned solex catheter.The catheter was returned to zoll with its shaft completely damaged.The catheter shaft was cut 10 cm away from the catheter tip.The catheter shaft was observed to be kinked at the proximal end of the serpentine balloon (8 cm away from the catheter tip).The exact timing and cause of the kink in the catheter cannot be determined; however, user handling during catheter removal cannot be ruled out.Due to the condition the catheter was in, functional testing could not be performed.Historical complaints were reviewed for the investigation related to the reported complaint, and there was no prior history of complaints for the solex 7 catheter with lot #206677.
Event or Problem Description
The solex 7 catheter (lot #206677) was inserted into the right ij (internal jugular) to initiate ivtm therapy.When attempting to remove the catheter, the nurse encountered resistance.Another nurse and two intensivists also tried to remove it at the bedside.A bedside ultrasound was performed, and the physician initially suspected a clot around the catheter.Ir (interventional radiology) was consulted for removal and recommended a vascular consultation.The hospital's cardiovascular (cv) surgeon took the patient to the operating room (or).The patient was positioned for carotid surgery, and after a timeout including identification, laterality, procedure, personnel, and consent, the physician made a 3 cm incision over the catheter site.Dissection through the sternocleidomastoid muscle was performed, following the catheter.At this point, enough soft tissue had been cleared to remove the catheter.Upon removal, the balloon was found to be no longer smooth.

• 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 ; 4084192347
• MDR Report Key: 23700722
• Report Number: 3010617000-2025-00814
• Device Sequence Number: 10673275
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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 Expiration Date: 03/31/2026
• Device Model Number: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: UNKNOWN
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown