MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL ICY INTRAVASCULAR HEAT EXCHANGE CATHETER KIT; CENTRAL VENOUS CATHETER

Model Number	8700-0782-01
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	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported event of 'catheter leak' was confirmed during functional testing.The most probable root cause is due to a latent bond defect.During visual inspection, there was no physical damage observed on the catheter.Blood residue observed on the catheter's balloons.During functional testing, all infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a pinhole leak was observed at proximal end of the distal balloon, thus confirming customer complaint.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 service information related to the reported complaint and there was no previous history of complaints reported for icy catheter with lot 92832.
Event or Problem Description
It was reported that prior to taking the patient for a ct scan, the coolgard system appeared to be functioning properly.Once the patient returned, the coolgard system was reconnected and turned on.The saline bag appeared to run empty, customer replaced the saline bag.However, the coolgard system displayed 'airtrap error message', the air trap was empty.Customer disconnected and re-prime the coolgard system; however, customer could not get all the air out of the tubing.Customer replaced the start-up kit, but the second saline almost ran dry again.Customer suspected there was a catheter leak.The catheter was replaced and the patient continue coolgard system treatment without any issue.No patient complications were reported.

• Brand Name: ZOLL ICY INTRAVASCULAR HEAT EXCHANGE CATHETER KIT
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8972866
• Report Number: 3010617000-2019-00781
• Device Sequence Number: 11469119
• Product Code: NCX
• UDI-Device Identifier: 00849111075237
• UDI-Public: 00849111075237
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/06/2019

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: 8700-0782-01
• Device Catalogue Number: 8700-0782-01
• Device Lot Number: 92832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1