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	04/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the icy catheter for investigation.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
At noon on (b)(6),2022 ivtm therapy was started with the target temperature set at 36 degrees.The patient had body temperature of 38 degrees.The icy catheter (lot #162644) was smoothly inserted in the right femoral vein on the first attempt.At 18:00, no decrease in saline in the saline bag was observed.At around 20:00, the saline in the saline bag had decreased by about 10 ml, but the customer thought it was due to the expansion of the air in the saline bag and ivtm therapy was continued.At midnight on (b)(6) 2022, during the maintenance phase, the customer observed that there was only 50ml of saline left in the saline bag and backflow of blood in the start-up kit (suk) was observed.The thermogard xp ivtm system did not generate an air trap warning alarm.The customer judged the issue was due to a balloon leak.About 200ml of saline infusion was suspected and ivtm therapy was discontinued because the temperature was maintained.The suk was checked for leaks but none were found.The dwell time was approximately 36 hours.On the morning of (b)(6) 2022, the catheter was removed.It was not removed at midnight because doctor was not there.No device malfunction was reported for the console and it is ready for use.No consequences or impact to patient.
Additional Manufacturer Narrative
The reported complaint of a leak on the icy catheter (lot #162644) was confirmed during functional testing.A bonding leak was observed at the proximal end of the distal 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 in the catheter balloons.During functional testing, all lumens and infusion ports were flushed without resistance.The catheter was connected to a pressurized inflation device.Upon pressurizing the catheter up to 100 psi, a bond 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 was no previous history of complaints reported for the icy catheter with lot number 162644.

• 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: 14501670
• Report Number: 3010617000-2022-00494
• Device Sequence Number: 5202619
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 162644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• 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