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	Hematoma (1884)
Date of Event	12/10/2014
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
(b)(6) year old white male was enrolled in the (b)(6) study.Patient condition at enrollment was comatose after cardiac arrest found in ventricular fibrillation.Zoll quattro catheter was inserted on (b)(6) 2014 @ 13:52h in the left femoral vein.Cooling initiated on (b)(6) 2014 @14:54h.Rewarming initiated on (b)(6) 2014@23:44h.The patient experienced adverse event 1: clinically significant hematoma, which occurred on (b)(6) 2014 @ 20:31 during hypothermia and was not intermittent.Outcome was resolved without sequelae on (b)(6) 2014@ 08:00h.Event reported as serious by investigator-life threatening, not related to device or procedure, was related to the patient's clinical condition, was related to treatment -cooling and adjunctive procedure and was anticipated.Subject received manual and mechanical pressure at site, administration of, or change to medications and prolonged hospitalization.Normothermia was achieved on (b)(6) 2014@15:30h.Catheter was removed on (b)(6) 2015@ (b)(6) 2014@2313h.The investigator reported the event as not related to study device malfunctions.Per the investigation, the patient had a hematoma/bleeding issue on both catheter (a-line in right groin and zoll catheter in left groin) insertion sites.As indicated above the patient was given medications and manual/mechanical pressure was performed with an eventual stop to the bleeding.

• 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: 5693532
• Report Number: 3010617000-2016-00254
• Device Sequence Number: 13730
• 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: 81 YR