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

Model Number	IC-3893
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the icy catheter (lot # 189629) could not be fully inserted was not confirmed during functional testing.No issues or discrepancies were found on the returned catheter.No device malfunction was observed during the testing, and the catheter functioned as intended.Visual inspection of the returned catheter was performed.There was no kink, and no physical damage observed on the catheter.Observed blood residue on the balloons.Functional testing 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 leak and no issues were found.The catheter functioned as intended.Additionally, a guidewire test was performed.A known-good zoll guidewire was slowly inserted into the tip of the catheter and exited through the distal infusion luered port without resistance.The guidewire could be passed through the entire length of the lumen with no resistance.
Event or Problem Description
The physician attempted to insert the icy catheter (lot # 189629) on the right femoral vein but observed an evident resistance with the guidewire, and the catheter could not be advanced.A new icy catheter and the guidewire were placed smoothly on the same location to continue the procedure.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: 18509198
• Report Number: 3010617000-2024-00035
• Device Sequence Number: 15485186
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/12/2024
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Weight: 65 KG