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

Model Number	CL-2295
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a cool line catheter (lot #162889) suspected to be leaking was confirmed during the functional testing.A leak was observed at middle of distal balloon during functional in/out lumen flushing test.The probable root cause of the reported complaint was due to a latent material defect.Visual inspection was performed, no physical damage was observed on the catheter.Noticed blood residues inside the catheter's balloons and luered tubings.All lumens were flushed without resistance.During in/out lumen flushing test, a leak was observed at middle of distal balloon.When observed the leak under the microscope, a circumferential tear in the balloon was observed at middle of distal balloon, thus confirming the reported catheter leak.Unable to perform the pressurized functional testing due to the condition in which the catheter was received.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.It is unlikely that the defective catheter was shipped.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for a catheter with a lot number (b)(4).
Event or Problem Description
During ivtm therapy, it was noted that blood tinged was observed within the closed looped of the start-up kit (lot #167955).Cool line catheter (lot #162889) suspected to be leaking.The catheter and suk were replaced and treatment continued with the same console.Per hospital's physicians, the catheter insertion was smooth into the patient's subclavian vein.No power injection occurred, no rapid transfusion occurred through line and no other lines noted within the same vessel.Catheter dwell time was 2 days.Patient's status information was requested but the customer did not provide a response.

• Brand Name: ZOLL IVTM COOL LINE 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: 13054707
• Report Number: 3010617000-2021-01201
• Device Sequence Number: 19247848
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/21/2021

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: CL-2295
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: 162889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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