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	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the customer observed light pink color in the saline bag and traces of blood tinge in the syringe, and a possible icy catheter (lot #184825)" was not confirmed during functional testing.During functional testing of the catheter, no leak or malfunction was observed, and the catheter functioned as intended.Visual inspection was performed and found light pink / yellow color inside the balloons and the in/out lumen tubings of the icy catheter.The root cause of the light pink / yellow in the catheter is unknown.No other physical damage was observed on the catheter.A functional pressure 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, and the balloons were fully inflated when pressurized up to 100 psi, no issues were observed.The balloons did not leak during inflation and deflation.The catheter functioned as intended.
Event or Problem Description
During ivtm therapy, the customer observed light pink color in the saline bag and traces of blood tinge in the syringe.The whole connection were checked for leak and no leak was observed.The icy catheter (lot #184825), start-up kit (suk) and saline bag were replaced and continued with treatment without any issue.Per reporter, at the first try, the catheter could not be fully inserted, but the second try was a smooth insertion into the patient left femoral vein.The physician has conducted 4 times ivtm hypothermia procedure.There was no alarm from the thermogard console during the treatment.No consequences or impact to 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 nguyen ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 17168522
• Report Number: 3010617000-2023-00527
• Device Sequence Number: 6574382
• 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): 06/20/2023

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: 8700-0657-01
• Device Lot Number: 184825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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