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

Model Number	IC-3893
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint that the physician noticed a red tinge in the in and out luer tubings of an icy catheter (lot #189629) was confirmed during the visual inspection and functional testing of the returned catheter.A leak from the proximal end of the distal balloon due to a balloon tear was observed during the functional in/out lumen test.The probable root cause for the reported complaint could be that the catheter balloon was torn during handling of the catheter.Visual inspection of the returned catheter was performed.No physical damage was observed on the catheter, and blood residues were noticed inside the balloons and luered tubings.Functional testing was performed, and all infusion ports and lumen were flushed without resistance.Upon flushing the in/out lumen, a leak from the proximal end of the distal balloon was observed, confirming the reported complaint.During the further inspection of the catheter under a microscope, a balloon tear was observed at the distal balloon, located 0.5cm away from the proximal end of the distal balloon.Pressurized functional testing could not be performed due to the 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 information related to the reported complaint, and there was no similar complaint reported for icy catheter with lot #189629.
Event or Problem Description
The physician inserted an icy catheter (lot #189629) into the patient's left femoral vein to initiate an ivtm therapy.After catheter insertion, and upon checking the catheter position, the physician noticed a red tinge in the in and out luer tubings.The catheter was immediately replaced with another icy catheter to initiate the therapy.No consequences or impacts 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: 18544329
• Report Number: 3010617000-2024-00064
• Device Sequence Number: 7852586
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2024

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: 8700-0657-01
• Device Lot Number: 189629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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