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

Model Number	IC-3893AE
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on 07/06/2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
A patient was hospitalized and underwent treatment for hypothermia.An icy catheter was inserted into the right femoral vein on (b)(6) 2017.On the evening of (b)(6)2017 the nurse raised concern that they have replaced the saline bag three times (3 x 1000 ml) throughout the day.The catheter was replaced with a cool line catheter and therapy was resumed.Upon removal, the customer confirmed leak in the icy catheter.No patient consequences were reported.
Additional Manufacturer Narrative
The customer reported complaint was confirmed during functional testing.A pinhole leak was noted at the middle of the medial balloon.The integrity of the catheter balloons are 100 % verified by subjecting them to pressure test during manufacturing.However, the balloon burst may be due to a latent material defect.A visual inspection of the returned catheter was performed and no abnormalities with the catheter was seen.All infusion ports flushed successfully.During functional testing, the returned catheter was connected to a pressurized inflation device and pressure was increased up to 100psi.Immediately upon pressurization, a pinhole leak was noted at the middle of the medial balloon.Historical complaints were reviewed and two previous complaints were reported for icy catheter (lot # 64907) for a catheter leak.They are ccr 24772 reported on (b)(6) 2016 and ccr 30234 reported on (b)(6) 2017.In both ccr's reported complaints were not confirmed.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6747711
• Report Number: 3010617000-2017-00520
• Device Sequence Number: 1602096
• Product Code: NCX
• UDI-Device Identifier: 00849111075077
• UDI-Public: 00849111075077
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/23/2017

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 Model Number: IC-3893AE
• Device Catalogue Number: 8700-0695-40
• Device Lot Number: 64907
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1