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 Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leak in the quattro catheter (lot 196842) was confirmed during the functional testing of the catheter.A water emission, leak was observed from the proximal luer port and at the proximal infusion lumen opening during the lumen crosstalk test.The probable root cause is a weakened wall between the lumens, which withstood pressure testing during manufacturing but resulted in a leak during clinical use.Visual inspection of the returned catheter was performed.No physical damage was observed on the catheter.Blood residue was observed on the balloons and in luered tubings.Functional testing of the returned catheter was performed.All the infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to the pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi, no leak was observed from the catheter balloons.However, a water emission, leak was observed from the proximal luer port and at the proximal infusion lumen opening during the lumen crosstalk test, confirming the reported complaint.Historical complaints were reviewed for information related to the reported complaint, and there was one similar complaint reported for the quattro catheter with lot 196842.Ccr (b)(4), reported on march 21, 2024 for a catheter leak.The investigation revealed a water emission/leak from the proximal luer port during the lumen crosstalk test.
Event or Problem Description
The thermogard xp ivtm system displayed an alarm to check the saline solution level.The saline bag was empty.The users checked the connections on the catheter, start-up kit (suk), and the air bubble trap.No leakage was found.A leak check was performed per the catheter ifu.The users flushed the quattro catheter (lot 196842) with saline and no saline came back out of the catheter.So, they decided to stop the therapy.The dwell time was 23 hours.The catheter was inserted into the right femoral vein of the female patient smoothly on the first attempt.The catheter and saline bag were replaced to continue therapy with the same console.No impact or injury to the patient.

• 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 ; 4084192922
• MDR Report Key: 20314055
• Report Number: 3010617000-2024-00756
• Device Sequence Number: 7862516
• 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): 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): 09/26/2024

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: 10/21/2025
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0783-40
• Device Lot Number: 196842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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