MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS X; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Complete Heart Block (2627)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Same case as mdr id# 2134265-2018-60917, 2134265-2018-60919, 2134265-2018-60918.It was reported that hypotension, third degree heart block and perforation occurred.During an ablation procedure for left atrial flutter, a polaris x, an intellamap orion, an intellanav mifi oi lrg curve and intellanav mifi oi std curve were selected for use.The physician mapped the left atrium using the orion mapping catheter while pacing from the coronary sinus (cs) catheter.He removed the orion from the left atrium and replaced it with an intellanav mifi oi lrg curve catheter.After coming on ablation for 3 seconds, the generator gave a d07 excessive temperature error.He changed ablation cables and inspected the catheter tip for evidence of char and did not see any.The real time temperature reading on the ablation generator was giving an internal temperature of 86 degrees.The physician did not reinsert the catheter into the body and replaced it with an intellanav mifi oi std curve ablation catheter and began to ablate.They were able to deliver radiofrequency (rf) without any errors and ablated.They did not notice any abnormal readings in regard to temperature, power and impedance.They ablated for roughly 2 minutes when the patient's blood pressure began to rapidly drop and the patient went into third degree heart block.Transesophageal echocardiography (tee) demonstrated a perforation and compressions were started.The procedure was stopped and resuscitation efforts were continued.The patient was then stable and was admitted to the hospital with the possibility of cardiothoracic (ct) surgery depending on how next few hours went.

• Brand Name: POLARIS X
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; dc a330,; saint paul MN 55112
• MDR Report Key: 7885062
• Report Number: 2134265-2018-60914
• Device Sequence Number: 186164
• Product Code: DRF
• UDI-Device Identifier: 08714729270164
• UDI-Public: 08714729270164
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K003452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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 Expiration Date: 12/12/2019
• Device Model Number: 86080
• Device Catalogue Number: 86080
• Device Lot Number: 0022278741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR