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	05/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An ivtm therapy was initiated using a quattro catheter (lot #unknown).During the therapy, the nurse noticed an emptying saline bag and realized that 250 ml saline bag was used instead of 500 ml saline bag.The 250 ml saline bag was emptying because upon priming, around 200-250 ml of saline will be circulating in the start-up kit (suk) tubing.The nurse replaced the bag with 500 ml saline bag to continue the therapy.During the cooling phase, the nurse noted decreasing volume of saline from the 500 ml saline bag.No leaked saline was noted around the thermogard xp ivtm system or on the patient's bed.The nurse suspected a catheter leak and called the zoll tech line for troubleshooting.Per zoll tech line personnel's instruction, the nurse performed the leak check on the catheter and noted blood backing up while performing the test.Zoll tech line personnel advised the customer to replace the catheter.The dwell time of the catheter was 23 hours.The customer left the catheter to use as a central line and end therapy.The customer reported no injury to a patient.
Additional Manufacturer Narrative
Zoll has not received the quattro catheter for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.

• 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: 19478647
• Report Number: 3010617000-2024-00436
• Device Sequence Number: 4072066
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/06/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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