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

Model Number	IC-4593AE
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the quattro catheter for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Event or Problem Description
The customer reported an inability to advance the catheter over the guidewire while attempting to insert the quattro catheter to initiate ivtm therapy for a 39-year-old male patient (weight: 85 kg).The customer experienced the same issue with two quattro catheters (lot #208148 and 209490).Additionally, the customer reported that the vessel dilator got kinked when attempting to dilate the blood vessel for catheter insertion.When attempting to pull the guidewire out of the catheter, the wire mesh came apart easily, making the guidewire unusable for another puncture attempt.The customer was able to insert another quattro catheter without any problems.No patient injury was reported.
Additional Manufacturer Narrative
The reported complaint of difficulty inserting a catheter was confirmed during visual and functional testing of the returned quattro catheter (lot #208148).A kink on the shaft was observed 10 cm from the catheter tip, making it difficult to insert the catheter over the guidewire.The precise timing and cause of the catheter kink are undetermined; however, user handling during insertion cannot be excluded.Due to the condition in which the catheter was received, the functional pressure leak test could not be performed.An additional guidewire test was performed: a known-good zoll guidewire was slowly inserted through the central lumen of the catheter; upon reaching the catheter tip, the guidewire became stuck 10 cm from the catheter tip due to a kink in the shaft.Historical complaints were reviewed for investigation related to the reported complaint, and there was no previous history of complaints reported for the quattro catheter with lot #208148.

• Brand Name: QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN E
• 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 ; 4084192347
• MDR Report Key: 23066502
• Report Number: 3010617000-2025-00632
• Device Sequence Number: 9822650
• Product Code: NCX
• UDI-Device Identifier: 00849111075275
• UDI-Public: 00849111075275
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/14/2025

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-4593AE
• Device Catalogue Number: 8700-0783-40
• Device Lot Number: 208148
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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 Age: 39 YR
• Patient Sex: Male
• Patient Weight: 85 KG