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

Model Number	IC-4593
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
A post cardiac arrest patient was inserted a quattro catheter without issue in the femoral vein.It was reported by the hospital nurse that after 4 hours into ivtm treatment, the saline bag was observed to be almost empty.The nurse replaced the start-up kit and saline bag and treatment was restarted.Twelve hours into ivtm treatment, loss of the saline in the bag was noted again.Upon inspection, no trace of blood was observed in the start-up kit and no leaks were observed on the bed and on the floor.Per follow up call with the nurse on the duty, 17 hours into ivtm treatment, the saline leak has stopped and level of saline in the bag has been unchanged.Doctor does not have any plans on replacing the catheter because patient reached target temperature.Since patient needs fluid, doctor is aware and not concerned of possibility for the additional saline getting into the patient.Per nurse, treatment has been continue smoothly.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
The reported event was confirmed during functional testing of the returned quattro catheter (lot # 78059).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 and a pinhole leak was observed on the distal and of the medial 2 balloon.During manufacturing, all 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.Thus, it is likely that either a latent deformity in the balloon that may have caused eventual leak under pressure, or the balloon may have seen higher stress during inflation.Historical complaints were reviewed for information related to the reported complaint and no similar history of complaint was reported for the quattro catheter with lot # 78059.

• 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: 7361624
• Report Number: 3010617000-2018-00365
• Device Sequence Number: 10791354
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/20/2018

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: IC-4593
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 78059
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1