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

Model Number	IC-3893AE
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	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B5 (describe event or problem) was updated.D4 (suspect medical device, brand name, model #, catalog #, lot #, expiration date, primary unique device identifier (udi) #) was updated.D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.H6 codes were updated.The reported complaint that the zoll catheter was ruptured was confirmed during the functional testing of the returned icy catheter (lot #195238).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.During the functional leak test of the returned catheter, 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 investigation results related to the reported complaint, and there was no previous history of complaints reported for the icy catheter with lot number 195238.
Event or Problem Description
The customer reported that the icy catheter (lot #195238) was ruptured.No additional information was provided.No harm 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.
Event or Problem Description
The customer reported that the zoll ivtm catheter (lot # unknown) was ruptured.No additional information was provided.No harm was reported.

• Brand Name: ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (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: 21819576
• Report Number: 3010617000-2025-00324
• Device Sequence Number: 20808183
• Product Code: NCX
• UDI-Device Identifier: 00849111075251
• UDI-Public: 00849111075251
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/07/2025

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: 09/25/2025
• Device Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 195238
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2023
• 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