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

Model Number 87035

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

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 07/20/2018

Event Type  Injury  

Event Description

It was reported a stroke occurred.An intellamap orion mapping catheter was selected for use during a pulmonary vein isolation (pvi) and atypical flutter procedure.During the procedure, atrial fibrillation and atypical flutter were mapped with the orion catheter and ablated with another manufacturer's ablation catheter.No abnormalities nor anything noteworthy occurred during the case; however, post procedurally the patient showed "suspicious behavior," specifically, the patient was awake but not able to speak and his tongue hung out.Neurological tests and a ct scan detected a thrombus in the brain.A thrombectomy was performed, but "it had already caused a lot of damage in the brain." the physician was convinced that the complication was not related to the orion, but had not found any reason that may explain the thrombus.Because the thrombus had caused such "huge damage" in the brain, it was assumed it had been stuck there for hours and must have happened at an early state of the procedure.The patient had an aortic valve replacement which "maybe had something to do with it." an ultrasound examination done prior to the procedure showed no thrombus in the heart.Activated clotting time (act) was above 300 seconds during the procedure and the catheter was flushed "all the time." the orion catheter had been working properly and no visual defects were noticed before or after the procedure.As of (b)(6) 2018, the patient had lost his ability to speak.

• 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; dc a330,; 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: 7796949
• MDR Text Key: 117582500
• Report Number: 2134265-2018-60048
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2018

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
• Device Operator: Health Professional
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/20/2018
• 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
• Treatment: ABLATION CATHETER: BIOSENSE WEBSTER THERMOCOOL SF; MAPPING SYSTEM: BOSTON SCIENTIFIC RHYTHMIA
• Patient Outcome(s): Required Intervention; Disability