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	Swelling/ Edema (4577)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported complaint of catheter leak was confirmed during the functional testing of the returned solex 7 catheter (lot #199921).A water emission or leak was observed from the distal end of the manifold during the lumen crosstalk test.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.Functional testing of the returned catheter was performed.All the infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the returned catheter was connected to the pressurized inflation; the balloon was fully inflated when pressurized up to 100 psi, and no leak was observed from the catheter balloon.However, a water emission or leak was observed from the distal end of the manifold during the lumen crosstalk test, confirming the reported complaint.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 similar complaint was reported for the solex 7 catheter with lot #199921.It seems that around 100 ml of sterile saline infiltrated tissues around the insertion site.The event was assessed as not serious because it did not meet the criteria for seriousness.Based on available information, the event was causal related to the zoll catheter due to relevant timing and location and no other obvious cause for such event.Swelling subcutaneous tissue around a catheter is an anticipated event and could potentially occur with the usage of any catheter.The event of "swelling subcutaneous tissue (infiltrate under the insertion site)" was causal related to the device and procedure.
Event or Problem Description
On october 9, 2024, a customer contacted the zoll tech line to report a suspected leak in the solex 7 catheter (lot #199921), which was noted on thursday, (b)(6) 2024.The rn observed swelling in the patient's left internal jugular vein where the solex catheter was inserted.The rn informed the provider, who then decided to discontinue therapy and remove the catheter.Upon removing the catheter, pressure was held to the insertion site to mitigate the swelling.The incident occurred during the maintenance phase of the hypothermia protocol, approximately 12 hours after the catheter had been placed.The customer reported that no alarms were triggered on the console.Additionally, the customer mentioned uncertainty about whether the saline bag had been replaced but noted that 400 ml remained from the original 500 ml bag.Since the target temperature goal of 36°c was reached, no further alternative therapy was initiated after removing the catheter.

• 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: 20589513
• Report Number: 3010617000-2024-00859
• Device Sequence Number: 8796964
• Product Code: NCX
• UDI-Device Identifier: 00849111075305
• UDI-Public: 00849111075305
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: SL-2593
• Device Catalogue Number: 8700-0793-01
• Device Lot Number: 199921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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: Other
• Patient Sex: Unknown