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

Model Number	IC-4593
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	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll catheter was returned to zoll on 01/30/2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
The patient was inserted a quattro catheter and received ivtm therapy.Approximately 12 to 24 hours into cooling therapy, the nurse observed blood on the catheter's luers.Upon inspection, no sign of leak on the start-up kit (suk), on the saline bag, or around the patient's bedside was observed.No alarm on the thermogard console was noted.A catheter leak was suspected.Following this, adjunct therapy (cooling pads) was used to continue the cooling therapy.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
The reported event was unable to be confirmed and a root cause could not be conclusively determined.The quattro catheter (lot # 78059) was not intact upon receipt.The distal and medial 2 balloons of the received catheter were detached from the rest of the catheter.Due to the received condition of the catheter, functional testing was not performed.All quattro catheters go through a thorough 100% inspection and test prior to and during catheter assembly process to ensure visual, structural and functional integrity.This includes destructive testing to verify burst strength prior to lot release.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported for the icy catheter with lot # 78059.

• Brand Name: ZOLL IVTM QUATTRO CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7263792
• Report Number: 3010617000-2018-00148
• Device Sequence Number: 1223551
• Product Code: NCX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/11/2018

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: IC-4593
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: 78059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1