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	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the reporter, the icy catheter (lot# unknown) was placed in the right femoral vein for the treatment utilizing the ivtm system.There were no documented issues during the catheter placement and no other lines were placed in the same vein.Two days after the treatment started, at the end of the re-warming phase, the user observed blood in start-up kit (suk) tubing and a decreased level of saline in the bag, confirming the catheter leak.The console was stopped by the nurse, and the therapy was discontinued as the patient was rewarmed.No consequences or impact to the patient.
Additional Manufacturer Narrative
The icy catheter associated with this complaint was not returned for evaluation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
The reported complaint of "the icy catheter (lot# 188005) suspected leak" was not confirmed during the functional testing of the returned catheter.No issues or discrepancies were found.No leak or malfunction was observed during testing, and the catheter functioned as intended.A visual inspection was performed.No physical damage was found on the catheter.Observed blood residues on the balloons and in the luered tubings.Functional testing 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, and no issues were observed.The balloons did not leak during inflation and deflation, and the catheter functioned as intended.Icy catheter (lot# 188005).
Event or Problem Description
Per the reporter, the icy catheter (lot# 188005) was placed in the right femoral vein for the treatment utilizing the ivtm system.There were no documented issues during the catheter placement, and no other lines were placed in the same vein.Two days after the treatment started, at the end of the re-warming phase, the user observed blood in start-up kit (suk) (lot# 185838) tubing, suspecting the catheter leak.However, the amount of saline fluid in the bag was not depleted.The infusion ports were tested by the customer and were noted to be functional as designed.The console was stopped by the nurse, and the therapy was discontinued as the patient was rewarmed.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 ; 4084192922
• MDR Report Key: 16882825
• Report Number: 3010617000-2023-00401
• Device Sequence Number: 7261948
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 188005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/06/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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