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	04/20/2015
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) male was enrolled into the (b)(6) study.Patient was brought to the enrolling facility on (b)(6) 2015 via emergency medical services after suffering from a cardiac arrest with an initial rhythm of ventricular fibrillation.Patient's condition at enrollment was comatose post cardiac arrest secondary to "massive mi" per history and physical.Zoll quatro ivtm catheter was inserted on (b)(6) 2015 at 12:44h in right femoral vein.Cooling initiated on (b)(6) 2015 at 13:57h.Target temperature achieved on (b)(6) 2015 at 06:00h.Rewarming initiated on (b)(6) 2015 at 06:00h.Normothermia achieved on at (b)(6) 2015 at 18:00h.The patient experienced adverse event 1, infection-pneumonia, which began on (b)(6) 2015 at an unknown time, during the normothermia/maintenance phase.Infection-pneumonia was resolved without sequelae on (b)(6) 2015 at an unknown time.Event reported by investigator as not serious, with a ctcae grade of 2, unrelated to the device or procedure, unrelated to the subject's clinical condition and anticipated.Event required change of existing medications.The patient was intubated.Catheter was removed on (b)(6) 2015 at 12:00h.Based on radiologists reports, the investigator determined the pneumonia to be intermittent.Pneumonia resolution date is approximated based on still being treated at discharge, with no mention at subsequent readmission.Investigator reported that the event was not related to study device malfunction.

• 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: 5693544
• Report Number: 3010617000-2016-00389
• Device Sequence Number: 18873696
• 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: 46 YR