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	02/06/2024
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 #195077) was confirmed during the visual inspection and functional testing of the returned catheter.A leak at 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.The catheter shaft was observed to be kinked in the middle of the distal balloon.The exact timing and cause of the kink on the catheter cannot be determined; however, improper handling of the catheter cannot be ruled out.Blood residue was observed in the balloons and luered tubings.No other physical damage was observed.Functional testing was performed, all infusion ports and lumen were flushed without resistance, except the in/out lumen tubing.During in/out flushing, a leak was observed from the distal balloon.Further inspection of the catheter under a microscope, a balloon tear measuring 4cm was observed, located at the proximal end of the distal balloon, confirming the reported complaint.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 previous history of complaints reported for the icy catheter with lot number 195077.
Event or Problem Description
During ivtm therapy, the icy catheter (lot# 195077) was inserted into the patient's left femoral vein with some resistance while inserting the catheter.There was no other central line placed on the same vein during the treatment.After the catheter was successfully placed, a red tinge in the tubing (in/out) was noted.The icy catheter leak check was not performed.The physician replaced only the icy catheter to initiate the therapy.The physician did not notice any issue with the guidewire.No consequences or impact to 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18882811
• Report Number: 3010617000-2024-00208
• Device Sequence Number: 2997197
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/11/2024

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: 195077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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