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

Catalog Number	8700-0654-01
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	11/26/2017
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 male patient weighing (b)(6) kg was hospitalized on (b)(6) 2017 with head trauma and underwent treatment for fever control.Cool line catheter was inserted into the internal jugular vein of the patient to begin treatment.Treatment was finished four days later ((b)(6) 2017) but the cool line catheter was not removed and the chemical-infusion lumen was used as a cv catheter.Next day, (b)(6) 2017, the chemical (propofol) was found to be leaking from the catheter insertion point and leak could not be stopped.The catheter was removed.No patient consequences were reported.
Additional Manufacturer Narrative
Evaluation of the returned cool line catheter could not confirm the customer reported complaint.The returned catheter is working as intended for use.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.Capping the "out" luer and connecting the "in" luer to the pressure inflation device.The catheter was pressure was increased up to 100psi and no leak was observed.Following the tests, all balloons deflated successfully without any issues.During manufacturing all cool line catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Probable causes of the reported issue could be due to the catheter may have moved so that the proximal port was no longer in the vein.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for cool line catheter with lot number 64010.

• Brand Name: ZOLL IVTM COOL LINE CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7153340
• Report Number: 3010617000-2017-01183
• Device Sequence Number: 16437573
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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 Catalogue Number: 8700-0654-01
• Device Lot Number: 64010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 70