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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the icy catheter in the 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
Once the customer connected the icy catheter (lot 193912) with the thermogard xp ivtm system, the nurses found saline reducing in the bag.Upon follow up, it was reported during the maintenance phase of ivtm therapy, the night shift nurse found the saline bag was almost empty.She checked all around the console and bed, and no saline leak was observed.She reported the issue to the physician on duty.When they removed the catheter to test it outside of the patient's body, they found a leak on the balloon of the catheter.The catheter and saline bag were replaced, and treatment was continued using the same console.The dwell time was 12 hours.No patient injury reported.
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot 193912) was confirmed during functional testing.A pinhole leak was observed at the middle of the medial balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.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 pinhole leak was observed at the middle of the medial balloon, confirming the reported complaint.Historical complaints were reviewed for information related to the reported complaint, and there were no similar complaints reported 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192947
• MDR Report Key: 20196030
• Report Number: 3010617000-2024-00723
• Device Sequence Number: 18053186
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/01/2024

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 Expiration Date: 07/09/2025
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/01/2024
• 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
• Patient Sex: Unknown