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

Model Number	IC-4593AE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	02/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The zoll catheter in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.
Event or Problem Description
A (b)(6) year old white female was enrolled into the (b)(6) study.Patient condition at enrollment was comatose after cardiac arrest with an initial rhythm of "no shock advised".Zoll quattro ivtm catheter was inserted on (b)(6) 2015 at 10:10.Cooling initiated on (b)(6) 2015 at 10:21.Target temperature achieved on (b)(6) 2015 at 11:05.The patient experienced adverse event 1: infection-pneumonia, which occurred on: (b)(6) 2015 at 06:47.The patient was intubated when the adverse event was discovered.Event required change of existing medications.The event was reported as serious, with a ctcae grade of 3, not related to the device or procedure, and related to the patient's clinical condition and anticipated.Rewarming initiated on (b)(6) 2015 at 13:00.Normothermia achieved on (b)(6) 2015 at 18:00.The patient expired on (b)(6) 2015 at 01:30.The event outcome was ongoing at the time of death.Adverse event onset occurred approximately 52 hours prior to quattro catheter removal.Catheter was removed on (b)(6) 2015 at 13:30.The investigator reported infection-pneumonia as not related to study device malfunctions.

• 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: 5693543
• Report Number: 3010617000-2016-00388
• Device Sequence Number: 13488332
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IC-4593AE
• Device Catalogue Number: 8700-0660-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2016
• Initial Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR