MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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	Cardiac Arrest (1762)
Date of Event	01/18/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Per customer, the staff did not save the catheter upon removal.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.The customer stated that the patient's death was not related to the zoll catheter.Event of death was serious because it met criteria for seriousness (death).Usually critically ill patients receive ivtm therapy and mortality rate is high.Probably outcome death related to the patient's clinical condition and not to ivtm therapy.Death is an anticipated event.The event of death is "not related" to the device and procedure.Event of "the fluid ran into the patient" was not serious because there was no impact to the patient due to the catheter leak.Leak was discovered quickly, and catheter was replaced.Seems that not much fluid entered the patient's vasculature.Administration of sterile cold saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals and should not harm a patient.The fluid ran into the patient's vasculature is an anticipated event.The event's (infusion of saline into the patient) relationship to the device and procedure is "causal.".
Event or Problem Description
The emergency department (ed) inserted a quattro catheter (lot unknown) for the first time and the balloon had a leak.The quattro catheter is new to their hospital, this was the first time it was inserted into one of their patients by a provider.They previously used icy and cool line.The leak occurred in the ed and was discovered quickly.The ed physician put in another catheter on the opposite groin.The site believes they used an icy catheter the second time.The same console was used to continue therapy.Upon follow up, the customer reported unfortunately, the female patient passed due to a cardiac arrest.The patient was brain dead.Ttm therapy had stopped.The site believes it was ended days prior.The staff did not save the catheter upon removal.No additional information was provided.Per the customer, her death was not related to the zoll catheter.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18726976
• Report Number: 3010617000-2024-00143
• Device Sequence Number: 20319401
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K072234
• 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): 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 01/25/2024
• Initial Report FDA Received Date: 02/16/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown