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

Model Number	IC-3893
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	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Toward the completion of the ivtm therapy, 43 hours after the therapy started, the nurse noted an empty 500ml saline bag and the air trap alarm went off on the thermogard console.The icy catheter (lot# unknown) was removed and the catheter leak was observed by the customer.No consequences or impact to the patient.Current patient status: awake, tracking following commands, and moving all extremities.The console was verified to be functional.
Additional Manufacturer Narrative
The zoll icy catheter was returned to zoll for evaluation, however, the investigation is pending.A follow up report will be filed when the investigation has been completed.
Event or Problem Description
Toward the completion of the ivtm therapy, 43 hours after the therapy started, the nurse noted an empty 500ml saline bag and the air trap alarm went off on the thermogard console.The icy catheter (lot #185797) was removed and the catheter leak was observed by the customer.No consequences or impact to the patient.Current patient status: awake, tracking following commands, and moving all extremities.The console was verified to be functional.
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot #185797) was confirmed during functional testing.A bonding leak was observed at the distal end of the proximal balloon during the functional pressure leak test.The probable root cause could be a latent defect at the bond.Visual inspection of the returned catheter was performed, and no physical damage was found on the catheter.A functional leak test of the returned catheter was performed.All infusion ports and lumens were flushed without resistance.During the functional pressure leak test, the catheter was connected to a pressurized inflation device.Upon pressurizing the catheter up to 100psi, a bonding leak was observed at the distal end of the proximal 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 a quattro catheter with lot number 185797.

• Brand Name: ZOLL IVTM ICY 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16793349
• Report Number: 3010617000-2023-00372
• Device Sequence Number: 17864735
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2023

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-3893
• Device Catalogue Number: 8700-0657-01
• Device Lot Number: 185797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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