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	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent ivtm therapy after cardiac arrest.The icy catheter (lot # 150201) was smoothly inserted into the patient's right femoral vein.The customer did not provide the patient's body temperature at the start of the ivtm therapy.During the maintenance phase of the treatment, the thermogard system displayed an "air trap" alarm.It was noted that the 500-ml saline bag was empty.The dwell time of the catheter was 90 hours when the issue happened.No traces of saline were observed on the floor, patient's bed, or on the console, ruling out the possibility of external leakage from the start-up kit (suk).The customer did not report if there was any blood tinge in the tubing.Since the therapy was almost completed, the catheter was removed.The customer flushed the catheter balloons with saline and observed a leak from one of the balloons.Infusion of about 250 milliliters of saline into the patient's bloodstream was suspected.The customer did not report any device malfunction on the thermogard console, and the console was placed back on the floor for further clinical use.No consequences or impact to the patient.
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot # 150201) was confirmed during functional testing.A bonding leak was observed at the proximal end of the medial balloon during the functional pressure leak test.The probable root cause was a latent defect at the bond.Upon visual inspection, no physical damage was observed.Dried blood residue was observed on the catheter balloons and inside the luered tubings.During functional testing, all lumens and infusion ports, and extension tubes were flushed without resistance.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 bond leak was observed at the proximal end of the medial 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 complaints reported for the icy catheter with lot number 150201.

• 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 12858664
• Report Number: 3010617000-2021-01082
• Device Sequence Number: 14526313
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: IC-3893
• Device Catalogue Number: 8700-0782-03
• Device Lot Number: 150201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• 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