MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); Thromboembolism (2654)

Event Date 12/21/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced a stroke.During a pulmonary vein isolation (pvi) and atrial tachycardia (at) ablation procedure, an atrial tachycardia map was made with an intellamap orion catheter of the right atrium and was successfully ablated with the intellanav mifi oi catheter at a power setting of 30w in the high lateral right atrium.A subsequent transeptal procedure was done, and a map was made of the left atrium and pulmonary vein ostia with the intellamap orion.A single ablation lesion was made on the anterior antral right superior pulmonary vein with the intellanav mifi oi at 30w power to isolate the vein.The procedure was completed successfully and the patient was woken from general anesthesia.The following day, it was noted that the patient had a stroke with notable slurred speech.The physician also stated that he recalled the intellamap orion catheter looked fuzzy on intracardiac ultrasound during the procedure and he suspects the stroke could have been related to an thrombus embolization from the orion catheter.He did state that this was not conclusive and the stoke could have originated from another "emoblic" source.It should be noted that the patient withheld their novel anticoagulant the day before the procedure under the direction of the physician.During the procedure, after initial femoral access, the patient was anticoagulated with heparin maintaining a target act>300ms throughout the procedure.The ablation impedance, power, and temperature were all within normal parameters during ablation and throughout the procedure.The flow rate through the ablation catheter was 2cc/min standby and 17cc/min during ablation.The orion was removed from the body during ablation.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora,; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8274123
• MDR Text Key: 133979601
• Report Number: 2134265-2019-00324
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2019

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
• Device Operator: Health Professional
• Device Model Number: M004RC64S0
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR