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

Model Number	IC-4593
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	07/11/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since there were no device deficiencies reported by the site, the device associated with this complaint will not be returned to zoll for physical evaluation.Based on the information provided by the site, there were no device deficiencies reported.The patient experienced cardiac arrest (presumably of cardiac origin), was resuscitated and had an initial rhythm of ventricular fibrillation.Rosc was achieved, the patient was intubated, admitted to the hospital and enrolled in the study.The patient experienced ventricular fibrillation again one day after admission during cooling procedure.Medications, three shocks were administered, and event was resolved without sequelae.Dysrhythmia is a common complication in post cardiac arrest patients.The site reported that event was related to the patient's post cardiac arrest clinical condition, and not related to study device or study procedure.
Event or Problem Description
A (b)(6) white male was enrolled into the (b)(6) study on (b)(6) 2015 at 15:30.There was no known cardiovascular medical history.The patient was a former smoker with no known history of alcohol use.On (b)(6) 2015 the patient had a witnessed out of office cardiac arrest at 13:10 with bystander chest compressions at 13:12 and bystander defibrillation at 13:15.The patient was brought into ems arrival at 13:30 with an initial rhythm of ventricular fibrillation.Rosc was achieved at 13:47.The patient was intubated on (b)(6) 2015.On admission, a pulse rate of 105 beats per min, respiratory rate of 15 breaths per min, and bp value of 60/50 mm hg were recorded.On the same day, ivtm quattro catheter was inserted into the left femoral vein at 18:00 successfully and cooling was initiated.Re-warming was initiated at 21:00.Catheter was removed on (b)(6) 2015 at 19:00.On (b)(6) 2015 at 23:59 less than 24 hours post initiation of cooling procedure and 24 hours prior to rewarming procedure, the patient experienced ventricular fibrillation, for which 3 shocks were administered.The patient also was treated with adrenaline and atropine and returned to rosc on (b)(6) 2015 at 00:08.Event was resolved without sequelae.On (b)(6) 2015, 22 days post enrollment, he was discharged to home in stable condition.On (b)(6) 2016, the patient completed 1 year follow up successfully.

• 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: 6296621
• Report Number: 3010617000-2017-00081
• Device Sequence Number: 19001437
• Product Code: NCX
• UDI-Device Identifier: 00849111075121
• UDI-Public: 00849111075121
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2017

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-4593
• Device Catalogue Number: 8700-0660-40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 02/02/2017
• 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; Required Intervention
• Patient Age: 40 YR