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

Model Number	IC-4593
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint for a quattro catheter leak was not confirmed during visual inspection and functional testing.Evaluation of the returned catheter revealed no issue with the catheter.The catheter functioned as intended.Note, during manufacturing, all quattro catheters are 100% inspected for leaks.In addition, extension tubing is also 100% tested for leaks.Only units that pass the testing are moved to the next process.A visual inspection of the returned catheter was performed.No abnormalities with the catheter was seen.All infusion ports flushed successfully, except the medial luer tubing.The medial luer tubing was noted to be clogged with blood.During functional testing, the catheter was connected to a pressurized inflation device.Capping the "out" luer and connecting the "in" luer to the pressure inflation device.The catheter was pressurized and no leak was noted.The balloons were able to deflate without difficulties.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for quattro catheter lot # 70556.
Event or Problem Description
A patient was hospitalized and underwent treatment for hypothermia.A zoll quattro catheter was inserted into the left femoral vein by a physician.24 hours after initiation of therapy, blood was noted inside the start-up kit (suk).The catheter was replaced and therapy was continued.No patient consequences were reported.

• 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: 6877886
• Report Number: 3010617000-2017-00720
• Device Sequence Number: 1312164
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2017

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: 8700-0791-01
• Device Lot Number: 70556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1