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	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Ivtm therapy was initiated for a male patient using a quattro catheter (lot #unknown), which was smoothly inserted into the patient's right femoral vein on the first attempt.The patient's initial temperature was 35.2°c, with a target temperature of 37°c set at the max rate.When the temperature reached 36.5°c, the thermogard xp ivtm system triggered an "air trap warning" alarm, and the customer noted an empty saline bag.The customer inspected the connections on the catheter, start-up kit (suk), and the suk air trap, finding no leaks.After flushing the catheter with saline, no saline was returned, leading the customer to suspect a catheter leak and decide to stop and finish the therapy.The customer suspects 250 ml of saline infusion into the patient's bloodstream.The dwell time of the catheter was two days.The air trap alarm was cleared and the thermogard system was placed back on the floor for future clinical use.No consequences or impacts on the patient.
Additional Manufacturer Narrative
Zoll has received the quattro catheter for investigation.A follow-up report will be submitted when the investigation has been completed.
Additional Manufacturer Narrative
Additional information in b5 (describe event or problem), d4 (lot #, expiration date), and h4 (device manufacture date).The reported complaint of catheter leak was confirmed during the functional testing of the returned quattro catheter (lot #196922).During the lumen crosstalk test, a water emission was observed from the proximal luer port and at the proximal infusion lumen opening.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.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 was observed from the proximal luer port and at the proximal infusion lumen opening during the lumen crosstalk test, confirming the reported complaint.It is unlikely that the defective catheter was shipped.All catheters are 100% inspected for leaks during manufacturing by subjecting them to pressure testing.Only units that passed are moved to the following process.Historical complaints were reviewed for investigation related to the reported complaint, and no similar complaint was reported for quattro catheter with lot #196922.
Event or Problem Description
Ivtm therapy was initiated for a male patient using a quattro catheter (lot #196922), which was smoothly inserted into the patient's right femoral vein on the first attempt.The patient's initial temperature was 35.2°c, with a target temperature of 37°c set at the max rate.When the temperature reached 36.5°c, the thermogard xp ivtm system triggered an 'air trap warning' alarm, and the customer noted an empty saline bag.The customer inspected the connections on the catheter, start-up kit (suk), and the suk air trap, finding no leaks.After flushing the catheter with saline, no saline was returned, leading the customer to suspect a catheter leak and decide to stop and finish the therapy.The customer suspects 250 ml of saline infusion into the patient's bloodstream.The dwell time of the catheter was two days.The air trap alarm was cleared and the thermogard system was placed back on the floor for future clinical use.No consequences or impacts on 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 ; 4084192347
• MDR Report Key: 20268921
• Report Number: 3010617000-2024-00733
• Device Sequence Number: 17935813
• 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): 10/22/2024

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: 10/29/2025
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0783-40
• Device Lot Number: 196922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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: Male