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

Model Number	8700-0654
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A cool line catheter was returned to zoll (b)(4) for evaluation.A visual inspection found no visual discrepancies or issues.All lumens flushed as intended.No leaks were noticed during flushing.The returned catheter was connected to a pressurized inflation device.A pinhole leak was noted at the proximal balloon immediately after pressurizing the catheter.Following the test, all balloons deflated successfully without any issues.Evaluation of the returned devices confirmed the customer reported issue as a cool line catheter pinhole leak at the proximal balloon.The probable cause for the customer reported issue was due to user mishandling, including, but not limited to damage during device operation.
Event or Problem Description
It was reported that cool line catheter was inserted in a left subclavian of a male patient ((b)(6)), the insertion was difficult.Three punctures were made.One complication was subclavian arterial puncture prior to getting correct placement.No water was noted on patient or around thermogard.Pinhole leak likely occurred to balloon.It was instructed to change catheter over guidewire.The catheter was placed in patient for 6 days.The airtrap chamber alarm was noticed during therapy.Patient is in a stable condition.

• 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: 5809474
• Report Number: 3010617000-2016-00489
• Device Sequence Number: 651817
• Product Code: NCX
• UDI-Device Identifier: 00849111075046
• UDI-Public: 00849111075046
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2016

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: 8700-0654
• Device Catalogue Number: 8700-0654-01
• Device Lot Number: 58912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2016
• Initial Report FDA Received Date: 07/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 94