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

Model Number	IC-4593
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a leaking quattro catheter lot #92029 was not confirmed.No issues or discrepancies were found during visual and functional testing.The catheter performed as intended.The root cause has been verified to be a leak on the suk, not on the catheter.Visual examination of the returned catheter was performed.No physical damage was found on the catheter.The balloons were examined and there were no tears, balloon bond detachment or rupture noted.Observed blood residues on the balloons.Functional testing of catheter was performed.All infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device, the balloons fully inflated when pressurized up to 100 psi without any issues.The balloons did not leak during inflation and deflation.No leak was observed.All lumens flushed as intended.Additional testing in peristaltic pump and console system: during functional testing, the retuned suk was connected to the returned catheter and placed in the peristaltic pump and ran for ten minutes.No leak was observed on the suk and also no leak was observed on the catheter.The returned suk was also connected to the returned catheter and tested in the tgxp thermogard system, running in the max warming mode with target temperature at 37°c.After 15 minutes, a leak was observed at the bottom air trap of the suk.No leak was found on the catheter.During manufacturing, all catheters are 100 % inspected for leaks by subjecting them to pressure testing.Only units that pass are moved to the next process.
Event or Problem Description
During intravascular temperature management (ivtm) therapy, customer reported that after 24 hours into the therapy, the saline bag has emptied.Saline fluid noticed draining from the insertion site.The quattro catheter lot #92029 was placed in the patient's right femoral vein with no difficulty.No fluid noted around the console, floor or around patient's bed.The facility nurse detached the start-up kit (suk) lot #093404 from the quattro catheter and ran a closed loop system to check for leakage in the tubing, no leak observed.The nurse replaced the 500ml saline bag, re-primed the tubing, and attached suk back to the catheter.Immediately saline bag started to empty again and fluid noted at insertion site.The quattro catheter and suk were replaced to continue therapy.The ivtm therapy was completed with no issue.No known impact or consequence to patient information was provided.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8833108
• Report Number: 3010617000-2019-00621
• Device Sequence Number: 2513898
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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-4593
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 92029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1