MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN); INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER

Model Number	IC-3893
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	07/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse in the icu contacted zoll to report that the thermogard xp ivtm system was repeatedly triggering air trap alarms, indicating air accumulation in the air trap chamber of the start-up kit (suk).The quattro catheter (lot #unknown) had been placed in the patient's left femoral vein without any other lines at the same site.The zoll technical support instructed the nurse to check the suk connections and verify its correct installation.There was no evidence of saline leakage around the thermogard console or near the patient.The nurse mentioned that the saline bag had been depleted once and subsequently replaced.The technical support emphasized that the saline bag should not be replaced in the future; instead, zoll should be contacted if it runs out.The nurse was informed of a suspected leak in the catheter balloon and was advised to have a healthcare provider remove the catheter and consider inserting a new one.No further information was provided.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
Zoll has not yet received the catheter in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A nurse in the icu contacted zoll to report that the thermogard xp ivtm system was repeatedly triggering air trap alarms, indicating air accumulation in the air trap chamber of the start-up kit (suk).The quattro catheter (lot #unknown) had been smoothly placed in the patient's left femoral vein without any other lines at the same site.The zoll technical support instructed the nurse to check the suk connections and verify its correct installation.There was no evidence of saline leakage around the thermogard console or near the patient.The nurse mentioned that the saline bag had been depleted once and subsequently replaced.The technical support emphasized that the saline bag should not be replaced in the future; instead, zoll should be contacted if it runs out.The nurse was informed of a suspected leak in the catheter balloon and was advised to have a healthcare provider remove the catheter and consider inserting a new one.The physician removed and replaced the suspected catheter.After the catheter was replaced, the air trap alarm was cleared.The nurse stated that the patient had developed lower extremity deep vein thrombosis (dvt).The reporting nurse added that scans were done to diagnose the dvt and heparin was started.No further information was provided.
Additional Manufacturer Narrative
The catheter in the complaint was returned to zoll on 18 september 2024 for evaluation.However, the investigation is still in progress.A follow-up report will be submitted when the investigation is completed.Only limited information is available about event of dvt.However, event of dvt was assessed as serious because based on available information, treatment with heparin was required.Event assessed as possibly related to the zoll catheter due to relevant timing of dvt.At the same time, the clinical condition of icu patient and immobility possibly contributed to development of current condition of dvt.Dvt is a known complication of central catheters of any kind.Patients in a critical condition are treated with ivtm.In such cases, those conditions make the patients predisposed to thrombogenicity.Development of thrombus is a common complication is such patient population.Critically ill patients are at increased risk of vte because of the presence of multiple predisposing factors [w.Geerts, et al.Venous thromboembolism and its prevention in critical care.J crit care, 17 (2002), pp.95-104].The rate of thrombosis for critical care patients receiving cvcs ranges from 20 to 30%, patients with peripheral central catheters had a significantly higher incidence rate of dvt than patients with cvc (27.2% vs 9.6%, p=0.0012).The rate of dvt in the patient population receiving ivtm post-cardiac arrest is 1.7%.Four randomized controlled clinical trials conducted in a total of 943 patients showed that there was no difference in the dvt rate when comparing zoll ivtm catheters to standard cvcs.The rate of dvt in the patient population receiving surface cooling has been reported between 3 and 15%.Timely administration of prophylactic anticoagulation is safe and significantly reduces dvt rates in high-risk patient populations [zoll white paper on dvt].Dvt is anticipated event and could potentially occur with usage of any catheter.The event is possibly related to the device and not related to the procedure.
Event or Problem Description
A nurse in the icu contacted zoll to report that the thermogard xp ivtm system was repeatedly triggering air trap alarms, indicating air accumulation in the air trap chamber of the start-up kit (suk).The icy catheter (lot #193912) had been smoothly placed in the patient's left femoral vein without any other lines at the same site.The zoll technical support instructed the nurse to check the suk connections and verify its correct installation.There was no evidence of saline leakage around the thermogard console or near the patient.The nurse mentioned that the saline bag had been depleted once and subsequently replaced.The technical support emphasized that the saline bag should not be replaced in the future; instead, zoll should be contacted if it runs out.The nurse was informed of a suspected leak in the catheter balloon and was advised to have a healthcare provider remove the catheter and consider inserting a new one.The physician removed and replaced the suspected catheter.After the catheter was replaced, the air trap alarm was cleared.The nurse stated that the patient had developed lower extremity deep vein thrombosis (dvt).The reporting nurse added that scans were done to diagnose the dvt and heparin was started.No further information was provided.
Additional Manufacturer Narrative
The reported complaint of a suspected leak in the catheter balloon was confirmed during functional testing of the returned icy catheter (lot #193912).A bonding leak was observed at the distal end of the medial balloon during the functional pressure leak test.The probable root cause of the reported complaint could be a latent defect in the bond.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, and the balloons were fully inflated when pressurized up to 100 psi.Upon pressurizing the catheter, a bonding leak was observed at the distal end of the medial balloon, 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 complaints for the icy catheter with lot number 193912.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN)
• Common Device Name: INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 20032887
• Report Number: 3010617000-2024-00634
• Device Sequence Number: 3075089
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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 Expiration Date: 07/29/2025
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 193912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 09/27/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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: Other
• Patient Sex: Unknown