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	03/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported issue of difficulty to advance the catheter into the patient was not confirmed during the icy catheter (lot # 172325) inspection.The good-known guidewire was drawn completely through the catheter distal tip, no problem was observed.The guidewire passed through the catheter without any resistance.The catheter worked as intended.A visual examination of the returned catheter was performed.No physical damage to the catheter was found.There was no kink observed on the catheter.Noted dried blood residue on the balloons and luered tubings.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 without any issues.The balloons did not leak during inflation and deflation.No leak was observed.
Event or Problem Description
During the icy catheter (lot # 172325) placement for ivtm therapy, the customer experienced difficulty while advancing the catheter over the guidewire.The user used a new guidewire and the second catheter was placed successfully to continue the therapy.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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131
• MDR Report Key: 14191176
• Report Number: 3010617000-2022-00421
• Device Sequence Number: 11856810
• 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): 04/24/2022

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: 172325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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