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
Additional Manufacturer Narrative
The reported complaint of "a possible icy catheter (lot #184223) balloon leak" was not confirmed during functional testing.No leak or malfunction was observed during testing, and the catheter functioned as intended.Visual inspection of the returned catheter was performed.No physical damage was found on the catheter.Observed blood residues on the balloons and in the luer tubings.A functional pressure leak test of the returned catheter was performed.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, the catheter functioned as intended.All infusion ports and lumens were flushed without resistance, except the medial luer tubing, due to blood clogging.
Event or Problem Description
An ivtm therapy was initiated for a 68-year-old male post-cardiac arrest patient (weight: 109 kg).An icy catheter (lot #184223) was placed into the right femoral vein with no evident complications per the physician.After 2 hours of therapy, the hospital staff noticed the returning ns (normal saline) was yellow in the start-up kit (suk) (lot #185857) tubing.There was no saline loss noted from the saline bag.Zoll clinical field trainer advised the customer of a possible catheter balloon leak and recommended placing the thermogard xp ivtm system in standby mode to replace the catheter.The customer notified the physician to replace the catheter.The catheter and the saline bag were replaced to continue and complete the ivtm therapy.The dwell time of the catheter at the time of removal was 5 hours.The patient is responsive, and all vital signs are stable.No adverse events or rhythm anomalies were witnessed.

• 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: 16888618
• Report Number: 3010617000-2023-00393
• Device Sequence Number: 6312330
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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: 8700-0782-01
• Device Lot Number: 184223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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