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	Death (1802)
Date of Event	01/05/2015
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.This patient with a past medical history of significant valvulopathy experienced ooh cardiac arrest, was resuscitated and admitted to the hospital.During hospital stay, his condition was poor, the patient experienced ventricular tachycardia and hypotension, which were assessed by treating doctor as related to the worsening of his previous clinical condition.Event was treated and resolved.The site reported that the event was related to the patient's clinical condition of post cardiac arrest syndrome, and not related to study device or study procedure.Myoclonic epileptic seizures occurred during normothermia maintenance part of the procedure.The patient was declining due to original condition caused ohca.The patient experienced acute renal failure and multisystem organ failure.The site reported that multiorganic failure was a cause of the patient's death.Events of myoclonic epileptic seizures, acute renal failure, and multisystem organ failure and death were reported as related to the pt's initial condition of postcardiac arrest syndrome and not related to study device or procedure.
Event or Problem Description
A (b)(6) white male was enrolled into the (b)(6) study on (b)(6) 2015 at 21:30 with a past medical history of significant valvulopathy, heart failure, asthma and chronic obstructive pulmonary disease, steinert's disease, zoster herpes, colonic resection, polycythemia, and cardiac valve surgery.The patient was a former tobacco user and never used alcohol.On (b)(6) 2015 the patient had a witnessed out of office cardiac arrest at 19:50.Before ems arrival, he received bystander chest compressions.Ems arrived at 19:55.The patient received ems treatment with cpr, defibrillation and medication.Rosc was achieved after ems arrival at 20:35 with initial rhythm of ventricular fibrillation.The patient was intubated on scene.On admission, a pulse rate of 80 beats per min and bp value of 125/65 mm hg were recorded.On the same day, ivtm quattro catheter was inserted successfully into the right femoral vein at 22:00 and cooling was initiated few minutes later.Re-warming procedure was initiated at on (b)(6) 2015 at 10:00.Catheter was removed on (b)(6) 2015 at 02:55.On (b)(6) 2015, at 00:00, 2 hours post initiation of cooling procedure, the patient experienced ventricular tachycardia.Due to onset of the arrhythmia, patient's pre-existing hypotension worsened.The episodes were intermittent and treated with amiodarone.After the initiation of treatment the ventricular tachycardia stopped but patient continued to have extra-systoles.The event was resolved without sequelae on (b)(6) 2015 at 00:00.Additionally, at the same time when cooling catheter was inserted and before cooling was initiated, the patient experienced bronchospasm.The patient was treated with medications and the event was resolved without sequelae on the same day at 23:00.On (b)(6) 2015 at 00:01, 24 hours post initiation of cooling procedure, the patient experienced hypotension with bp value of 110/56 mmhg.The patient was treated with medications.The patient remained hypotensive until he died later on (b)(6) 2015 but was not an immediate cause of the patient's death.On (b)(6) 2015, at 14:00, 2 days post initiation of cooling procedure, the patient experienced myoclonic epileptic seizures.The patient was treated with medications and the event was resolved without sequelae on the same day at 22:00.Additionally, on the same day, at 14:30, during normothermia maintenance, and 1 day before the catheter was removed, the patient developed acute renal failure.The patient received hemofiltration.The event was not resolved until the time when the patient died but was not an immediate cause of the patient's death.On the same day, at 15:00, during re-warming, the patient went into multisystem organ failure due to mixed shock, which was treated with medications.The site reported that the event was serious (life-threatening and required treatment to prevent permanent impairment).The site reported that the event was related to the patient's clinical condition of post cardiac arrest syndrome, and not related to study device or study procedure.The event eventually resulted in patient death on (b)(6) 2015 at 02:53,3 days post enrollment.Catheter was removed after patient death in icu at 2:55.The site reported that the death was not related to the study device or study procedure.

• 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: 6296646
• Report Number: 3010617000-2017-00082
• Device Sequence Number: 13611808
• 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: Death; Other
• Patient Age: 70 YR