MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the quattro catheter in the complaint for investigation.A supplemental report will be filed when the investigation has been completed.
Event or Problem Description
The customer reported that during the maintenance phase of ivtm therapy, blood-tinged fluid was seen in the saline bag and in the lines connecting to the thermogard xp ivtm system.The patient was at the target temp of 33c.The console did not alarm and the saline bag was not depleted.Therapy was stopped and the physician was notified.A leak on the quattro catheter (lot unknown) is suspected.The catheter was placed in the right femoral vein.The dwell time was approximately 2 days.Ivtm was discontinued because the patient was being re-warmed already.No device malfunction was reported for the console or the start-up kit (suk) (lot unknown).No impact or consequence to the patient was reported.
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot 188005) was confirmed during functional testing.A pinhole leak was observed at the proximal end of the distal balloon during the functional pressure leak test.The probable root cause of the pinhole leak was a latent material defect.Visual inspection was performed, and no physical damage was found on the catheter.Dried blood residue was observed in the balloons and luered tubings.Functional leak test 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.Upon pressurizing the catheter up to 100 psi, a pinhole leak was observed at the proximal end 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 were no similar complaints reported for the icy catheter with lot number 188005.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17072513
• Report Number: 3010617000-2023-00488
• Device Sequence Number: 12288357
• Product Code: NCX
• UDI-Device Identifier: 00849111075084
• UDI-Public: 00849111075084
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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: 188005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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