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 Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of catheter leak was confirmed during the functional testing of the returned solex 7 catheter (lot #201702).During the functional in/out lumen test, a pinhole leak was observed at the distal end of the serpentine balloon.The probable root cause of the pinhole leak was a latent material defect.A functional leak test of the returned catheter was performed, and all infusion ports and lumen were flushed without resistance.During the in/out lumen test, a pinhole leak was observed at the distal end of the serpentine balloon (4th loop from the tip), thus confirming the reported complaint.Pressurized functional testing could not be performed due to the pinhole leak discovered during the in/out lumen test.It is unlikely that the defective catheter was shipped.All catheters are 100% inspected for leaks during manufacturing by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for investigation related to the reported complaint, and no previous history of complaints was reported for the solex 7 catheter with lot #201702.
Event or Problem Description
An ivtm therapy was initiated for a cardiac arrest patient using a solex 7 catheter (lot #201702) and a thermogard hq start-up kit (suk) #1 (lot #204066).Following the set-up and during the initiation of therapy, a saline leak was identified in the suk #1 tubing, which was inserted into the roller pump of the thermogard hq system.The customer replaced the suk #1 but observed a similar leak in the suk #2 (lot #204066) tubing at the same section of the tubing.Following the second replacement, the customer noted a blood tinge (indication of catheter leak) in the suk #3 (lot #204066) tubing.Per the customer, no blood tinge was observed in the first two suk tubings.The customer placed the thermogard hq system on standby after the leak was noted and before the "air trap warning" alarm.The customer suspects less than 200 ml of saline infusion into the patient's bloodstream.The dwell time of the catheter was less than an hour.Consequently, therapy was discontinued with the thermogard hq system and was resumed using an alternative temperature management system.No consequences or adverse impact on the patient.
Additional Manufacturer Narrative
Submitting a supplemental mdr to include the received medsun report number 0700220000-2024-8405 in the corresponding section h, related report number field.

• 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: 20860386
• Report Number: 3010617000-2024-00958
• Device Sequence Number: 4032268
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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 Model Number: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 201702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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