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

Model Number	IC-3893CO
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	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When the physician opened the icy catheter kit (lot # 191568) and tested the catheter prior to insertion for an ivtm theray, a leak was detected in the catheter's balloon.A new catheter was used to start the treatment.No further information was provided.No patient injury was reported.
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.
Additional Manufacturer Narrative
D4 (suspect medical device, expiration date) was updated.D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The customer's complaint of a catheter's balloon leak was confirmed while flushing the returned icy catheter (lot #191568) during the decontamination process.During the in/out lumen flushing, a leak was observed from the proximal end of the distal balloon due to a tear in the balloon.During functional testing, all infusion ports and lumen were flushed without resistance.Upon flushing the in/out lumen, a leak was observed from the proximal end of the distal balloon.Further inspection of the catheter under a microscope showed a balloon tear located 1.5 cm away from the proximal end of the distal balloon, confirming the reported complaint.Pressurized functional testing could not be performed due to the leak discovered during the in/out lumen test.Historical complaints were reviewed for investigation results related to the reported complaint, and there was no previous history of complaints reported for the icy catheter with lot number 191568.
Additional Manufacturer Narrative
H6 code (type of investigation) was corrected from 4109 to 4110.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE CUSTOM LUER
• 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: 21692356
• Report Number: 3010617000-2025-00215
• Device Sequence Number: 21187112
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• 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,Followup
• Report Date (Section B): 05/28/2025

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: 05/12/2025
• Device Model Number: IC-3893CO
• Device Catalogue Number: 8700-0782-14
• Device Lot Number: 191568
• 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: 03/02/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 05/28/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 05/15/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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