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

Model Number	CL-2295AE
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on 11/10/2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Reference mfr #: 3010617000-2017-00964.(b)(4).
Event or Problem Description
A patient was hospitalized post cardiac arrest and intravascular temperature management was needed for fever management.A zoll cool line catheter was inserted into the left subclavian vein by an experienced physician.The insertion was smooth.The indwell time of the catheter was seven days.On the seven days after therapy was initiated, an air trap alarm was noted.The catheter was removed since the therapy was completed.The patient temperature prior to the ivtm therapy was 40 degree celsius.The target temperature on the console was 37 degree celsius.The patient's temperature has improved and no longer needs an ivtm therapy.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 was found approximately in the middle of the distal 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 middle of the distal balloon.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for cool line catheter lot # 68090.

• 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: 7047389
• Report Number: 3010617000-2017-00975
• Device Sequence Number: 11112389
• Product Code: NCX
• UDI-Device Identifier: 00849111075213
• UDI-Public: 00849111075213
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2017

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-2295AE
• Device Catalogue Number: 8700-0781-40
• Device Lot Number: 68090
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 95