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

Model Number QUATTRO CATH, IC-4593/IC-4593AE

Device Problems Kinked (1339); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

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 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.

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
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7661557
• MDR Text Key: 113306902
• Report Number: 3010617000-2018-00686
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1