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

Model Number	CL-2295
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	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
A patient was hospitalized and an intravascular temperature management was needed for fever management.A zoll cool line catheter was inserted into the subclavian vein.The indwell time of the catheter was three days.The attending nurse noted blood coming back up into the circulating ports of the cool line.The catheter was replaced to continue with the treatment.No patient consequences were reported.
Additional Manufacturer Narrative
Evaluation of the returned catheter confirmed the customer reported complaint as a cool line catheter pinhole leak at distal end of the proximal balloon.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 for the reported complaint can be a latent material defect.Visual inspection found no visual discrepancies or issues.All lumens flushed as intended.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.Immediately upon pressuring the catheter, a pinhole leak was noted at the distal end of the proximal balloon.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint for cool line catheter leak with lot # 66447 under ccr 24911 reported on (b)(6) 2016.The reported leak was not confirmed during evaluation.

• 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: 7003833
• Report Number: 3010617000-2017-00872
• Device Sequence Number: 1676532
• Product Code: NCX
• UDI-Device Identifier: 00849111075190
• UDI-Public: 00849111075190
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/30/2017

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: CL-2295
• Device Catalogue Number: 8700-0781-01
• Device Lot Number: 66447
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1