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

Model Number	8700-0671
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
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.It should be noted that some proposed explanations of death provided by physician are massive pulmonary embolism (pe), spinal shock and magnesium overdose.Thus death was probably related to the patient's clinical condition and not related to ivtm catheter or procedure.
Event or Problem Description
It was reported that solex 7 catheter was used for treatment of therapeutic hypothermia(th) in a patient with cardiac arrest(ca) due to breathing distress (hanging committed suicide).Patient had glasgow coma scale 8, agitated anoxic cephalopathy, and normal blood pressure(bp) without any vasopressor.Th started after 8 hours of ca because physician needed time to rule out head and spinal injuries.Everything was noted to be fine(bp, oxygenation, electrolyte).The temperature went down quickly to reach 33°c after 3 hours.However 10 hours after initiating th, patient suddenly had cardiac collapse and was not responsive to cpr, and then patient died.Some proposed explanations for death provided by physician are massive pulmonary embolism(pe), spinal shock and magnesium overdose.Additional information was provided by physician saying that there are many reasons contributing to patient's death.Patient had severe depression, drug abuse and hanging (suicidal attempt) at the same time.Patient had some family problems.Use of cpr or first aid in the community in (b)(6) is not so standard before arrival to the hospital.The catheter used for the th treatment has been discarded, physician mentioned that he did not think that death of patient is related to catheter use.It seemed the patient had circulatory collapse and there was no desaturation before that event.During the procedure there was no premature beat or arrhythmia.The x- ray did not confirm if the tip of catheter went to the right atrium and ventricles.The catheter was put via right subclavical vein.The patient was diagnosed by family member as having cardiac arrest, however physician mentioned that this information is not reliable.When the medical staff arrived, patient had achieved rosc.As physician could not rule out ca, they started th therapy.Note: physician mentioned that this is the first case they have informed zoll about.Physician think that th therapy is quite good.Patient did not have good outcome may be due to other possible reasons.Physician believe that patient might have addicted to some drugs or preexisting heart problem and therefore had sudden severe arrhythmias.

• Brand Name: ZOLL IVTM SOLEX CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5699290
• Report Number: 3010617000-2016-00377
• Device Sequence Number: 16315242
• Product Code: NCX
• UDI-Device Identifier: 00849111075152
• UDI-Public: 00849111075152
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K081936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2016

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: 8700-0671
• Device Catalogue Number: 8700-0671-01
• Device Lot Number: 57968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2016
• Initial Report FDA Received Date: 06/03/2016
• 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: Death