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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
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.
 
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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 Key8274123
MDR Text Key133979601
Report Number2134265-2019-00324
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143481
Number of Events Reported1
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 NumberM004RC64S0
Device Catalogue Number87035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2019
Initial Date FDA Received01/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
INTELLANAV MIFI OPEN-IRRIGATED
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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