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

Model Number	IC-3893
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	02/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint was confirmed during the functional testing of the returned icy catheter (lot #190479).During the functional pressure leak test, a leak from the catheter's shaft was observed at 3.5cm away from the distal end of the manifold.The root cause of the reported complaint was due to a small sharp cut.The suture needle or other sharp tools, such as a scalpel, may have accidentally cut the catheter shaft, which is attributed to user error.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.Blood residues were observed on the balloons and luer tubings.A functional leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.The catheter was connected to a pressurized inflation device during the functional pressure leak test.Upon pressurizing the catheter up to 100psi, a leak from the catheter's shaft was observed 3.5cm away from the distal end of the manifold, confirming the reported complaint.In addition, the returned catheter was inspected under a microscope, and a very small sharp cut was noticed on the catheter's shaft.No leak was observed from the balloons.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 information related to the reported complaint, and there was no previous history of complaints reported for the icy catheter with lot #190479.
Event or Problem Description
During the cooling phase of the ivtm therapy using an icy catheter (lot #190479), the customer noticed blood in the start-up kit (suk) tubing, and the saline bag was noted to be emptied.The dwell time of the catheter was 5 hours.The catheter was replaced to continue the therapy using the same thermogard xp ivtm system.No consequences or impact on the patient.

• Brand Name: ZOLL IVTM ICY 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: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18813399
• Report Number: 3010617000-2024-00171
• Device Sequence Number: 4343047
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 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): 02/29/2024

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: IC-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 190479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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