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

Catalog Number	8700-0654-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2017
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
The patient was inserted a cool line catheter and achieved normothermia on day 4 of ivtm therapy; however, the hospital personnel observed that the saline bag was empty.No physical signs of leak was observed on the floor and on the patient's bedside.After catheter removal, fluid was reportedly observed to be leaking out of the catheter although the reporter was unable to identify the specific site of the leak within the catheter.No adjunctive temperature management was performed.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
The reported event was confirmed during functional testing of the returned cool line catheter (lot # 64685).Visual inspection of the catheter upon receipt revealed no abnormalities.All lumens flushed as intended.The catheter was functionally tested by connecting to an inflation device, capping the "out" luer and connecting the "in" luer to the pressure inflation device.The catheter was pressurized and immediately, a pinhole leak was observed at the middle section of the distal balloon.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported for the cool line catheter with lot # 64685.Note that the integrity of the balloons are verified on 100% of the catheters by subjecting them to pressure test during manufacturing; however, the visual observation on the catheter balloon may be due to a latent material defect or the balloon may have seen higher stress during insertion or removal.

• 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: 6777766
• Report Number: 3010617000-2017-00593
• Device Sequence Number: 2066346
• 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: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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 Catalogue Number: 8700-0654-01
• Device Lot Number: 64685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1