MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM QUATTRO CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-4593
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	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The quattro catheter (lot # 188009) was used in an ivtm therapy.The catheter was inserted into the patient's right femoral vein to initiate the treatment.The cooling and rewarming phases of the treatment were completed, and the patient was rewarmed for at least 12 hours.The catheter remained in place to help support normothermia.During the normothermia phase of the treatment, the staff noticed that the 500-ml saline bag was dry.The staff placed the thermogard system in standby mode and performed a catheter leak check.Per the physician, 10-15 ml of saline was injected into the in luer of the catheter, and only a small amount of saline returned.The catheter leak was discovered around 4 or 5 am, and the treatment was discontinued because temperature management therapy was already completed.Later during the day shift, the catheter was removed from the patient.No consequences or impacts on the patient.
Additional Manufacturer Narrative
The reported complaint of the "catheter leak" was confirmed during functional testing of the returned quattro catheter (lot # 188009).During the functional pressure leak test, a bonding leak was observed at the distal end of the medial 1 balloon.The probable root cause of the bonding leak could be a latent defect in the bond.A visual examination of the returned quattro catheter was performed and found no physical damage to the catheter.Dried blood residue was observed inside balloons and luer tubings.During functional testing, 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 1 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 information related to the reported complaint, and there was no previous history of complaints reported for the quattro catheter with lot number 188009.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17140613
• Report Number: 3010617000-2023-00511
• Device Sequence Number: 18093499
• Product Code: NCX
• UDI-Device Identifier: 00849111075282
• UDI-Public: 00849111075282
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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-4593
• Device Catalogue Number: 8700-0783-01
• Device Lot Number: 188009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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