MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER; 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	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/1/24 at 03:13, a nurse contacted the technical support line to report an issue with the start-up kit (suk): the flow indicator (red pinwheel) did not spin (though the roller pump was active) while attempting to cool a patient in max power mode via a solex 7 (lot # unknown) catheter placed in the right internal jugular vein on (b)(6) 2024.The patient was not achieving the target temperature of 37°c with the current patient temperature of 37.8°c.No loss of liquid or alarms were observed.Settings and setup were verified, confirming the device was in run mode and the tubing was free of kinks.The technical support team advised tapping the pinwheel on the suk gently to release any air, but this did not resolve the issue.After pausing therapy, disconnecting, repriming, and reconnecting the suk tubing, the same problem persisted.A new console and suk setup were implemented, but the issue continued.The customer disconnected the suk from the catheter, reconnected it in a closed loop, and verified it was functioning as expected.After inspecting the solex 7 catheter per the ifu, the customer attempted to flush the in and out luers to check saline flow; while saline did flow, resistance was noted.A cooling blanket was used to assist in reaching the target temperature for the patient, and a catheter exchange was recommended for continued ivtm treatment.No consequences or impact to the patient.
Additional Manufacturer Narrative
The solex 7 catheter associated with this complaint was not returned for evaluation as it was discarded by the customer.Therefore, a physical investigation of the catheter could not be performed.

• Brand Name: SOLEX® INTRAVASCULAR HEAT EXCHANGE 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: 20802892
• Report Number: 3010617000-2024-00934
• Device Sequence Number: 9254156
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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