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	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Two hours after initiating an ivtm therapy using the icy catheter (lot #184646), the customer reported observing blood in the start-up kit (suk) tubing.The customer noticed this before the thermogard system generated any "air trap" alarm, and there was no report of a decrease in the saline bag volume.The customer paused the thermogard console, removed the catheter, and noticed blood in the catheter as well.The customer suspected a catheter leak and replaced the catheter.The customer also decided to replace the suk due to the presence of blood in the tubing.It is unknown how much saline might have infused into the patient's bloodstream.No patient injury was reported.
Additional Manufacturer Narrative
The icy catheter (lot #184646) was returned to zoll with its shaft completely cut 1 inch away from the distal end of the manifold.However, blood residue was observed in the distal balloon.Blood inside the catheter typically is indicative of a leak somewhere in the catheter; thus, confirming the reported complaint of a "suspected catheter leak".Since the catheter was returned cut, functional testing could not be performed, and zoll cannot precisely determine the leak location or type of the leak.Visual examination of the returned catheter did not show any other physical damage(s).Functional testing could not be performed due to the condition in which the catheter was returned.Therefore, the root cause of the reported complaint could not be determined.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.

• 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: 17549926
• Report Number: 3010617000-2023-00678
• Device Sequence Number: 20504099
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/15/2023

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: IC-3893
• Device Catalogue Number: 8700-0782-03
• Device Lot Number: 184646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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