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

Model Number	CL-2295AE
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	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported complaint of the cool line catheter (lot # 151301) leak was confirmed during functional testing.A pinhole leak was observed from the middle of the distal balloon.The probable root cause for the reported complaint could be due to a latent material defect.The customer statement of the broken catheter could not be verified during the visual inspection as no physical damage was noted.Visual inspection of the returned catheter was performed and found no physical damage to the catheter.The blood residues were observed on the balloons and in all luered tubings.A functional leak test of the returned catheter was performed, and all lumens were flushed without resistance, except distal and medial luered ports due to blood clogged.The catheter was connected to a pressurized inflation device for one minute, and the balloons were fully inflated when pressurized up to 100 psi.Immediately upon pressurizing the catheter, a pinhole leak was observed from the middle of the distal 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 similar complaint reported for the cool line catheter with lot # 151301.It is unknown if some amount of sterile saline entered the patient's vasculature.Seems the customer didn't use additional bags with saline but stopped procedure.Administration of sterile cold saline i.V.Up to 1.5 l is one of the common methods of treatment at the hospitals and should not harm a patient.
Event or Problem Description
During patient treatment, the cool line catheter (lot # 151301) was placed in the jugular vein without any issues.After 2 hours of the treatment, the user observed the blood coming from the catheter both in and out luers into the start-up kit's tubing, indicating the catheter leak.The thermogard console (sn (b)(4)) generated an air trap alarm and the console stopped.The patient treatment was stopped after removing the catheter, however, the specifics of the alternative therapy were not disclosed.After removing the catheter, the customer examined it and observed a damaged balloon.No consequences or impact to the patient.The customer stated that the catheter got broken in the patient's jugular vein, the patient hasn't deteriorated due to this incident though and a new catheter has been inserted successfully.However, the customer did not provide the details on the exact time of the observed broken catheter issue and how the patient treatment was completed.After the treatment, the console was tested with the demo suk and was confirmed as functional.No consequences or impact to the patient.See mfr 3010617000-2021-00672 for thermogard console (sn (b)(4)).
Additional Manufacturer Narrative
The fluid ran into the patient's vasculature is an anticipated event.No patient's effect was observed.Additional information, h10.

• 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: 12156846
• Report Number: 3010617000-2021-00593
• Device Sequence Number: 3857126
• Product Code: NCX
• UDI-Device Identifier: 00849111075060
• UDI-Public: 00849111075060
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CL-2295AE
• Device Catalogue Number: 8700-0654-40
• Device Lot Number: 151301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/29/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other