MAUDE Adverse Event Report: OSCOR INC. HELIOS FLOW DIRECTED TEMPORARY PACING LEAD WITH BALLOON; ELECTRODE, PACEMAKER, TEMPORARY

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Death (1802); High Blood Pressure/ Hypertension (1908); Ventricular Tachycardia (2132); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/10/2017

Event Type  Death  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.

Event Description

The customer reported during the transcather aortic valve replacement (tavr) procedure the pacing maker wire was placed.At the end of the procedure the patient's blood pressure was low.An echocardiogram was done and it was discovered that the patient had developed a pericardial effusion nearing the point of a tamponade.A pericardiocentesis was performed and the patient was transferred to critical care.It was discovered that the cardiac effusion/tamponade was caused by a perforation of the right ventricular wall by the pacing wire.The patient did not recover and died.Per cardiac interventionalist: "it was noted that the patient became somewhat hypotensive.Transthoracic echocardiogram documented a new pericardial effusion and a subxiphoid cap was performed with evacuation of approximately 10 ml of bloody fluid.Microcatheter was then placed into the pericardial space and a bubble test confirmed the location.A wire was placed through the microcatheter and this was exchanged for a pigtail drain which was placed near the pericardial cavity.Withdrawing of approximately 400-500 ml of bloody fluid ensued with stabilization of hemodynamics." per critical care md pt required "high dose vasopressors to maintain hemodynamics.Although initially, he appeared to stabilize.He had a catastrophic decline late in the afternoon of (b)(6) 2017 that seemed to be initiated a conversion of his rhythm to afib with rvr (rapid ventricular response) with rates in the 140-150s.Attempts were made to perform synchronized cardioversions due to his poor tolerance of this rhythm; however, successful cardioversions only occurred after a full iv amiodarone load.Unfortunately he continued to deteriorate with profound hypoxia and acidosis and increasing pressor requirements.It was evident that organ perfusion was extremely poor and further efforts to assure his survival was felt to be increasingly futile.".

Manufacturer Narrative

A device history record review could not be performed as the model number provided by the reporter, h05110, was not valid.Additional information has been requested, however not received as of date of this report.Inspection procedures require the helios temporary pacing lead pass all in-process and qa final inspection steps before shipping to the customer, including balloon, inflation/deflation and leak testing.The device was in use for treatment.There was no deficiency with the device reported observed during the procedure.The lead was not available for return and there was no specific allegation brought against the lead.No investigation was required as there was no device failure reported in this event.Per instructions for use (ifu), listed in the possible complications and warnings, section a, it states that myocardial perforation can occur as a complication.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.

• Brand Name: HELIOS FLOW DIRECTED TEMPORARY PACING LEAD WITH BALLOON
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• Manufacturer Contact: dorit segal ; 3816 desoto blvd; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 7169599
• MDR Text Key: 96562856
• Report Number: 1035166-2018-00002
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 91 YR