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

Model Number	CL-2295
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the zoll catheter in complaint 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 post cardiac arrest and underwent treatment for hypothermia on (b)(6) 2017.A week after the treatment was initiated, the nurse found blood that entered about half way into the start-up kit (suk) tube.The nurse clamped down the tube and as soon as the physician received the report from the nurse, the cool line catheter was removed.The physician believes there was no health damage to the patient.No other information was provided.
Additional Manufacturer Narrative
A cool line catheter (lot # 62920) was returned to zoll (b)(4) for evaluation.Evaluation of the retuned devices confirmed the customer reported issue as a cool line catheter pinhole leak.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.During visual inspection, white adhesive tape was found attached to the catheter shaft and was not removed.No other discrepancies or issues were noted.The returned catheter was connected to a pressurized inflation device.A leak was observed when the pressure was increased up to 40 psi.A pinhole leak was noted at the proximal end 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 a cool line catheter sn (b)(4).Correction was made to (date of the event) as (b)(6) 2017.

• 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: 6464577
• Report Number: 3010617000-2017-00278
• Device Sequence Number: 580007
• 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): 05/30/2017

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: 8700-0654-01
• Device Lot Number: 62920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1