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	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll did not receive the catheter in complaint for investigation.A follow-up report will be filed if and when the product is returned and an investigation has been completed.
Event or Problem Description
At noon on (b)(6), preparations were made to initiate hypothermia treatment using the thermogard xp ivtm system.The nurse began priming the start-up kit (suk) (lot#: 208126) according to standard procedures.However, when the air trap holder was positioned and the prime switch was held for over three minutes, the suk's pinwheel did not rotate at all.The doctor decided to use another suk, which was successfully primed.The icy catheter (lot#: 209536) was successfully placed to initiate the hypothermia treatment.However, the doctor immediately noticed blood leaking from the catheter's orange ports (both in and out luers).It was suspected that the catheter's balloon was leaking.The icy catheter and saline bag were replaced, and the procedure was initiated.No consequences or impacts on the patient.
Additional Manufacturer Narrative
B5 (describe event or problem) was corrected for the catheter's lot number.D4 (suspect medical device, lot #) was corrected.D4 (suspect medical device, expiration date) was updated.D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.H6 codes were updated.The reported complaint of a suspected catheter balloon leak was confirmed during the functional testing of the returned icy catheter (lot # 209530).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.The nature and location of the tear suggest it was likely caused by contact with a sharp instrument, such as a suture needle or scalpel, during handling or use of the catheter.During functional testing, all infusion ports and lumens were flushed without resistance, except for the proximal luer port, which was clogged by blood in the tubing.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 revealed a balloon tear located at 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.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 209530.
Event or Problem Description
At noon on (b)(6), preparations were made to initiate hypothermia treatment using the thermogard xp ivtm system.The nurse began priming the start-up kit (suk) (lot # 208126) according to standard procedures.However, when the air trap holder was positioned and the prime switch was held for over three minutes, the suk's pinwheel did not rotate at all.The doctor decided to use another suk, which was successfully primed.The icy catheter (lot # 209530) was successfully placed to initiate the hypothermia treatment.However, the doctor immediately noticed blood leaking from the catheter's orange ports (both in and out luers).It was suspected that the catheter's balloon was leaking.The icy catheter and saline bag were replaced, and the procedure was initiated.No consequences or impacts on the patient.

• 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: 21905795
• Report Number: 3010617000-2025-00302
• Device Sequence Number: 11777085
• Product Code: NCX
• UDI-Device Identifier: 00849111075251
• UDI-Public: 00849111075251
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Physician
• Type of Report: Initial,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 Model Number: IC-3893AE
• Device Catalogue Number: 8700-0782-40
• Device Lot Number: 209530
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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