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

Catalog Number	8700-0791-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on (b)(6) 2017 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
As reported, a quattro catheter was inserted after about 6 to 12 hours into ivtm therapy, the thermogard console displayed an air trap alarm.Upon inspection, the saline bag was observed empty.No physical signs of leak on the floor and on the patient's bedside was observed.The hospital personnel eventually exchanged to another quattro catheter to complete the ivtm treatment.No adjunctive temperature management was performed.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
No issue was observed during evaluation of the returned quattro catheter (lot # 71602).The report of leak was not confirmed.Visual inspection of the catheter upon receipt revealed no abnormalities.All lumens flushed as intended.The catheter was functionally tested by connecting to an inflation device, capping the "out" luer and connecting the "in" luer to the pressure inflation device.The catheter was pressurized up to 100 psi and the pressure was observed for one minute without any leak.In addition, lumen crosstalk test was performed, capping the "out" luer and connecting the pressure inflation device to the medial, distal and proximal luer.The catheter was pressurized and no leaks were noted with all the three lumens.Following the tests, all balloons deflated successfully without any issues.Historical complaints were reviewed for information related to the reported complaint and there was no similar complaint reported for the quattro catheter with lot # 71602.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.

• 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: 6757475
• Report Number: 3010617000-2017-00546
• Device Sequence Number: 16647728
• Product Code: NCX
• UDI-Device Identifier: 00849111075503
• UDI-Public: 00849111075503
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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 Catalogue Number: 8700-0791-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 64