MAUDE Adverse Event Report: ZOLL CIRCULATION, INC ICY-3, JAPAN, FINAL PACKAGED KIT (APPLAUSE); 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	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
At approximately 11:00 pm on (b)(6) 2024, ivtm therapy began using an icy catheter (lot 201537) for the cardiopulmonary arrest patient.At approximately 1:00 am on (b)(6) 2024, an alarm sounded on the thermogard xp ivtm system indicating a saline leak.The amount of saline in the saline bag had decreased, so a syringe was connected to the in luer and blood was confirmed when it was drawn in.Since there was no spare thermogard catheter, temperature management was continued with arctic sun.The alarm on the console was cleared.No device malfunction reported for the start-up kit.No patient injury was reported.
Additional Manufacturer Narrative
The reported complaint of a leak on icy catheter (lot 201537) was confirmed during functional testing.A pinhole leak was observed at the middle of the distal 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 distal balloon, confirming the reported complaint.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 number 201537.

• Brand Name: ICY-3, JAPAN, FINAL PACKAGED KIT (APPLAUSE)
• 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 ; 4084192922
• MDR Report Key: 20355838
• Report Number: 3010617000-2024-00789
• Device Sequence Number: 8127116
• Product Code: NCX
• UDI-Device Identifier: 00849111050043
• UDI-Public: 00849111050043
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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 Expiration Date: 01/06/2026
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0657-03
• Device Lot Number: 201537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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