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

Model Number	8700-0660-01
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	01/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on 01/24/2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
The patient was inserted a quattro catheter for ivtm therapy.The user initially experienced difficulty inserting the quattro catheter (getting the line in place) on the patient.Approximately 1 hour after insertion, blood was observed in the in/out lumens of the catheter that connects to the start-up kit (suk) as well as blood on the start-up kit tubing, thus suspecting a likely catheter leak.Following this, the user placed another catheter on the other groin of the patient without further issue observed.No known impact or patient consequence was reported.Additional information from the manufacturer's clinical field representative stated that the person who performed the insertion is experienced with catheter placement.The catheter balloons were not inflated prior to catheter placement.
Additional Manufacturer Narrative
The reported catheter leak was confirmed.The catheter's distal balloon and the distal end had a tear upon inflating.Visual inspection of the returned catheter was performed.No abnormalities with the catheter were seen.During functional testing, the catheter was connected to a pressurized inflation device.Immediately upon pressurizing the catheter, a leak was observed on the distal balloon.No leakage due to crosstalk was observed 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.Probable causes for the reported complaint can be a latent material defect.Historical complaints were reviewed for related complaint with quattro lot# 73768; there was one other complaint reported on (b)(6) 2017 due to a confirmed leak at the proximal end and medial balloon.

• 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: 7226767
• Report Number: 3010617000-2018-00074
• Device Sequence Number: 11134207
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 04/11/2018

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: 8700-0660-01
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 73768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1