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	Cardiac Arrest (1762)
Date of Event	01/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot # 181290) was confirmed during functional testing.A bonding leak was observed at the proximal end of the distal balloon during the functional pressure leak test.The probable root cause could be a latent defect at the bond.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.Blood residues were observed in the medial luered tubing.A functional leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device.Upon pressurizing the catheter up to 100psi, a bonding leak was observed at the proximal end of the distal balloon, thus confirming the reported complaint.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported for a quattro catheter with lot number 181290.Seems that around three 200ml of sterile cold saline was 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 of the catheter leak relationship to the device and the procedure is casual.The patient's death is not related to a study device but related to a post cardiac arrest clinical condition.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.Death is an anticipated event.The event of death is not related to the device and the procedure.
Event or Problem Description
On (b)(6) 2023 at 12:50 pm, a cardiopulmonary arrest (cpa) patient (81 years old female) with a temperature of 28.7°c was brought to the hospital.The ivtm therapy using an icy catheter (lot # 181290) began at 1:37 pm.On (b)(6) 2023, at 0:15 am, during the warming phase of the treatment, an air trap alarm went off and the device was paused.The customer discovered that the saline bag was nearly empty (about 200ml of saline had been infused) and there was a backflow of blood in the start-up kit (suk) (lot # 182403), confirming the catheter leak.The customer decided to remove the catheter, however, the reason for not continuing the ivtm therapy was not provided.At 1:13 pm, the customer confirmed the patient's death.At the time of death, the patient had a fever of more than 39°c.The request for additional information received limited response.The relationship between the catheter leak and death is unknown.The console was verified to be functional.
Additional Manufacturer Narrative
Seems that around 200ml of sterile cold saline was 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.

• 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: 16397988
• Report Number: 3010617000-2023-00155
• Device Sequence Number: 5685458
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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-3893
• Device Catalogue Number: 8700-0782-03
• Device Lot Number: 181290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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 Age: 81 YR
• Patient Sex: Female