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	Insufficient Information (4580)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a quattro catheter (lot #163925) leak was confirmed during the functional testing.A pinhole leak was observed at proximal end of the medial 2 balloon during the functional pressure leak test.The probable root cause of the pinhole leak was due to a latent material defect.Visual examination of the returned catheter was performed, and no physical damage was observed.Noticed dried blood residue inside the catheter's balloons and luer tubings.Functional leak test of the returned catheter was performed, and all infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed at proximal end of the medial 2 balloon; thus, 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 complaint reported for quattro catheter with lot number 163925.
Event or Problem Description
During rewarming phase of ivtm therapy, it was noticed that the thermogard ivtm system generated an "air trap" alarm and customer noticed blood in the start-up-kit tubing and the 500ml saline bag had emptied.The quattro catheter (lot #163925) suspected to be leaking.Patient temperature was at 98.1c degrees and decreased to 97.4c degrees when the blood was noted in the start-up-kit.The quattro catheter was inserted smooth into the patient's left femoral vein.Per reporter, no issue when removing the catheter, and no fluid came out the balloon.Catheter dwell time was 3 days.The customer was able to clear the "air trap" message and the thermogard functioning properly.Warming blankets was used to continue with treatment, since patient had completed most of the rewarming treatment.Patient's status information was requested but the customer did not provide a response.

• 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: 12763921
• Report Number: 3010617000-2021-01023
• Device Sequence Number: 19915039
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/06/2021

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: 8700-0791-01
• Device Lot Number: 163925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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