MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM COOL LINE CATHETER; CENTRAL VENOUS CATHETER

Model Number	CL-2295
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	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the ivtm therapy, a cool line catheter (lot # 175892) was inserted into the patient's left femoral vein.After approximately 45 minutes of therapy, the console generated an "air trap" alarm and the nurse observed a 500ml saline bag empty, the saline was also noted leaking from the insertion site.Per the reporter, the introducer was placed in the same vein before the catheter placement.In addition, catheter infusion ports were utilized during the catheter use, however, the reporter does not remember particular ports that were used.The infusion of the 500ml of saline fluid and the catheter leak was suspected.The new cool line catheter was placed in the right subclavian vein to continue the therapy with the same console.No consequences or impact to the patient.
Additional Manufacturer Narrative
The zoll cool line catheter was not returned to zoll for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
The customer reported the cool line catheter leak on lot # 175892, however, we received the cool line catheter lot #172802 for investigation.The reported complaint of "catheter leak" was not confirmed during visual and functional testing of the returned cool line catheter.No issues or discrepancies were found on the catheter.No leak or malfunction was observed during testing, and the catheter functioned as intended.The customer's secondary complaint of the leak at the insertion site was not confirmed during the functional testing of the returned catheter.The most likely cause for the saline leak from the injection site was likely due to the improper placement of the catheter, however, the patient's anatomy cannot be ruled out.Visual inspection of the returned catheter was performed.There was no physical damage observed on the catheter.Observed blood residues on the balloons and luered tubings.A functional pressure leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance, except the proximal luered tubing due to blood clogging.The catheter was connected to a pressurized inflation device, and the balloons were fully inflated when pressurized up to 100 psi, and no issues were observed.The balloons did not leak during inflation and deflation.In addition, the returned catheter was connected to the returned suk and ran on a peristaltic pump for 10 minutes at a high-speed rate.No leak no damage was found during testing, and the catheter was performed as intended.During further functional testing, the returned catheter was connected to the returned suk and tested on the thermogard console system.The catheter was run in the max warming mode with a target temperature of 37°c for 60 minutes and in the max cooling mode with a target temperature of 35°c for 60 minutes.The balloons were observed to warm correctly during the warming mode and cool correctly during the cooling mode.No leaks or damages were detected on the catheter and it functioned as expected.The suk red pinwheel and pump roller were observed to be rotating normally.D4: cool line catheter (lot# 172802).
Event or Problem Description
During the ivtm therapy, a cool line catheter (lot # 172802) was inserted into the patient's left femoral vein.After approximately 45 minutes of therapy, the console generated an "air trap" alarm and the nurse observed a 500ml saline bag empty, the saline was also noted leaking from the insertion site.Per the reporter, the introducer was placed in the same vein before the catheter placement.In addition, catheter infusion ports were utilized during the catheter use, however, the reporter does not remember particular ports that were used.The infusion of the 500ml of saline fluid and the catheter leak was suspected.The new cool line catheter was placed in the right subclavian vein to continue the therapy with the same console.No consequences or impact to the patient.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131
• MDR Report Key: 15858524
• Report Number: 3010617000-2022-01984
• Device Sequence Number: 12223768
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/11/2023

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: CL-2295
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: 172802
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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