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	07/25/2015
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 (b)(6) -year old male post cardiac arrest patient developed post-anoxic encephalopathy during hospital stay and his condition and prognosis were poor, had severe cerebral disability and was dependent on others for daily functions.The patient condition did not improve, cerebral performance category scale was 4 since discharge.3 months post catheter removal, the patient died at nursing care center due to post-anoxic encephalopathy.Site reported that cause of death was "terminal wean/hospice care".Per conversation with family, decision was made to withdraw care.Death occurred at long term skilled care nursing facility.Site reported that death was related to clinical condition of the pt with poor prognosis and not related to study device or procedure.
Event or Problem Description
A (b)(6) -year old male was enrolled in the frost study on (b)(6) 2015 at 14:51 with a past medical history of rib fracture and pneumothorax.The patient never used tobacco or alcohol.On (b)(6) 2015, at 11:55, the patient had a witnessed out of office cardiac arrest at a public place.Before ems arrival he received bystander chest compressions at 11:57.Ems arrived at 12:09, the patient was treated with cpr and defibrillation.Rosc was achieved at 12:19 with initial rhythm of ventricular fibrillation.The patient was intubated on scene.At admission, a pulse rate of 110 beats per minute, bp value of 135/75 mm hg, and respiratory rate of 16 breaths per min were recorded.On the same day, ivtm quattro catheter was successfully inserted into the right femoral vein at 14:30 and cooling was initiated at 16:00.Rewarming procedure began on (b)(6) 2015 at 18:00.Catheter was removed on (b)(6) 2015 at 11:00.On (b)(6) 2015 at 09:00, 3 days post initiation of cooling procedure, during normothermia maintenance, the patient symptoms of the patient's post-anoxic encephalopathy got worsened.The site reported that the event was serious (resulted in significant disability or incapacity and required prolonged hospitalization.On (b)(6) 2015, 2 month post catheter removal, the patient was discharged to long term skilled care nursing facility.Neurological assessment of cerebral performance category score on that day revealed that the patient was conscious, had severe cerebral disability and was dependent on others for daily functions.The patient condition did not improve, cerebral performance category scale was 4 since discharge.On (b)(6) 2015, at 10:00, 3 months post catheter removal, the patient died at nursing care center due to post-anoxic encephalopathy.

• 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: 6296687
• Report Number: 3010617000-2017-00083
• Device Sequence Number: 13710938
• 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: 52 YR