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

Model Number	QUATTRO CATH, IC-4593/IC-4593AE
Medical Device Problem Codes	Kinked (1339); Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on 06/13/2018 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, the guidewire with unknown lot number was a bit difficult to push back after insertion of quattro cath (ln 68874) on the patient's femoral right side.The dwell time of the catheter was 14 hours.Therapy started successfully but after few hours later, the thermogard xp ivtm system with unknown serial number target temperature could not reached fast and precise.Patient's target temperature was 33°c however, the patient temperature stayed at 36°c.X-ray results showed that there was a little kink of the catheter, and also, the red wheel (flowindicator) at the suk with unknown lot number was not moving.Additionally, the role-pump gas moved.No leaked fluid observed.There were no system alarms noticed during therapy.Experienced practitioners has decided to removed the catheter about 14 hours into the patient therapy and was cooled with conventional methods, e.G.Coolpacks and saline.Resuscitation was the primary cause for the patient hospitalization.No intervention needed or planned due to the event.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
The reported quattro catheter (ln 68874) leak was not confirmed.A visual inspection of the returned catheter was performed.The balloons were examined and there were no tears, balloon bond detachment or rupture noted.Visual examination found no physical damage.The balloons were examined and there were no tears, balloon bond detachment or rupture noted.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The catheter was connected to a pressurized inflation device, the balloons fully inflated when pressurized up to 100 psi without any issues.The balloons did not leak during inflation and deflation.No leak was observed.All lumens flushed as intended.Please note, during manufacturing, all catheters are 100 % inspected.Only units that pass 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: 7661557
• Report Number: 3010617000-2018-00686
• Device Sequence Number: 19109624
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: QUATTRO CATH, IC-4593/IC-4593AE
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 68874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1