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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120)
Date of Event	01/15/2015
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 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) 2015@ 15:54h in the right femoral vein.The patient experienced adverse event: excessive bleeding, which occurred on (b)(6) 2015@ 1656h during hypothermia and was intermittent.Per the investigation, the patient's excessive bleeding at the right groin was secondary to integrilin.Integrilin stopped, femstop/compression applied at the site.Outcome was resolved without sequelae on (b)(6) 2015@ 17:39h.Event reported as not serious by investigator, not related to device or procedure, was not related to the patient's clinical condition, was not related to treatment, and was anticipated.The investigator reported event as not related to study device malfunctions.Cooling initiated on (b)(6) 2015 @ 18:30h.Rewarming initiated on (b)(6) 2015@ 19:00h.Normothermia was achieved on (b)(6) 2015@ 03:00h.The patient experienced adverse event: infection-other urinary tract infection, which occurred on (b)(6) 2015@ 15:21 after normothermia was achieved and was not intermittent.Outcome was ongoing at the time of death on (b)(6) 2015.Catheter was removed on (b)(6) 2015@08:20h.Event reported as not serious by investigator, not related to device or procedure, was related to the patient's clinical condition, was not related to treatment and was not anticipated.The patient received administration of, or change to medications and prolonged hospitalization.The investigator reported the urinary tract infection as not related to study device malfunctions.Per the investigation, mae category infection.The event was ongoing at the time of death.

• 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: 5693540
• Report Number: 3010617000-2016-00255
• Device Sequence Number: 13526152
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Hospitalization; Other
• Patient Age: 56 YR