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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint of a "cool line catheter (lot #151932) leak" was confirmed during the functional testing.A leak from the middle of the distal balloon due to balloon tear was observed.The probable root cause for the reported complaint was a latent material defect.Visual inspection of the returned catheter was performed.The customer returned the catheter inside the small specimen container and thereby caused the catheter to be kinked, unrelated to the reported complaint.A kink on the catheter shaft was observed at 10 cm away from the catheter tip.In addition, noticed dried blood residue on the catheter balloons and the in/out luered tubings.During functional testing, all infusion ports and extension tubes were flushed without resistance.Upon flushing the in/out lumens, the leak was observed from the middle of the distal balloon.In addition, the returned cool line catheter was inspected under a microscope, and a small straight line cut measuring 4mm was observed in the middle of the distal balloon.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 following process.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for the cool line catheter with lot number 151932.
Event or Problem Description
During ivtm therapy for a (b)(6) patient using a cool line catheter (lot #151932), the user observed an empty saline bag and noticed blood backing up into the start-up kit (suk) tubing.The user reported a catheter leak and approximately 500 ml of saline infusion into the patient body.The cool line catheter was removed from the patient, and the specifics of further or alternative treatment were not provided.No additional information was provided.No consequences or impact to the patient.

• 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
• MDR Report Key: 12351833
• Report Number: 3010617000-2021-00740
• Device Sequence Number: 20116417
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 151932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR