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

Model Number	IC-4593
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	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter involved in the reported complaint will not be returned for investigation because the customer has disposed of it.Therefore, a physical investigation could not be performed, and the root cause could not be determined.
Event or Problem Description
During the ivtm therapy using a quattro catheter (lot #unknown), the customer noticed saline volume depletion of approximately 125 ml while in the maintenance phase of therapy.The thermogard xp ivtm system (sn (b)(6) ) did not generate an alarm, and the patient was at the goal temperature of 33°c.The dwell time of the catheter was approximately 6 hours.No leaked saline was noted on the patient's bed or around the thermogard system, and no blood tinge was noted in the tubing.The catheter leak was performed per ifu, and no leaks were noted.Saline out flowed from the catheter when injected as expected, and negative pressure was maintained.Zoll tech support asked the customer to pause the therapy and replace the catheter; however, the physician decided to end intravascular therapy and use external temperature controls.No device malfunction was reported on the thermogard system, and it was placed back on the floor for treating other patients.No consequences or impacts on the patient.

• Brand Name: ZOLL IVTM QUATTRO 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19067864
• Report Number: 3010617000-2024-00334
• Device Sequence Number: 20521150
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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-4593
• Device Catalogue Number: 8700-0783-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/08/2024
• 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