MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT 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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint was confirmed during the functional testing of the returned icy catheter (lot #189836).During the functional pressure leak test, a bonding leak was observed at the proximal end of the medial balloon.The probable root cause of the reported complaint could be a latent defect in the bond.Visual inspection of the returned catheter was performed, and no physical damage was observed on the catheter.Blood residue was observed in the balloons.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 up to 100 psi when pressurized.Upon pressurizing the catheter, a bonding leak was observed at the proximal end of the medial balloon, which confirmed the reported complaint.It is unlikely that the defective catheter was shipped.All catheters are 100% inspected for leaks during manufacturing 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 reported for the icy catheter with lot #189836.
Event or Problem Description
On (b)(6) 2024, an ivtm therapy (normothermia) was initiated for a stroke patient using an icy catheter (lot #189836).The next morning, on (b)(6) 2024, the hospital team noted that the 500 ml saline bag emptied more than usual.Per the nurse, the team assessed any leaked saline around the thermogard system, on the patient's bed, or loose connections, but it was unclear if a good assessment was performed.So, the nurse troubleshot the catheter by performing the leak check per ifu.The saline returned as expected, and no blood was noted while holding the vacuum.The team replaced the start-up kit (suk) and saline bag to continue the therapy.The following morning, on (b)(6) 2024, the team noted that the 500 ml saline bag was emptying again more than usual.The team decided to put the thermogard xp ivtm system on standby mode and remove the catheter.The catheter was removed, and the team placed an esophageal cooling probe to continue the therapy.The customer suspects around 500 ml of saline infusion into the patient's bloodstream.The dwell time of the catheter at the time of the issue was approximately 18 hours, and removal was approximately 34 hours.No consequences or impacts on the patient.
Additional Manufacturer Narrative
Correction in d1 (brand name), d2 (common device name), d3 (manufacturer name), and g1 (contact office - manufacturing site).Additional information in h10 (related report numbers).

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT 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; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19534157
• Report Number: 3010617000-2024-00496
• Device Sequence Number: 20917241
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 10/02/2024

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-3893
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: 189836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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
• Patient Sex: Unknown