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 Data Problem (3196)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that the patient experienced ventricular tachycardia and ventricular fibrillation.A ventricular tachycardia ablation procedure was performed using the rhythmia hdx mapping system with a patient that had a non-boston scientific ventricular assist device (vad) placed in the apical left ventricle.An intellamap orion catheter was placed across into the left ventricle (lv) via transeptal approach.Magnetic localization of the intellamap orion was lost immediately after entering the lv.The vad flow rate was reduced from 3200rpm to 2500rpm, which significantly reduced electromagnetic interference and allowed for tracking of the orion catheter.The orion catheter was then used to map the lv substrate, however, magnetic interference still occurred in the lower, apical third of the left ventricle when in proximity to the cannula of the vad.This area of the lv as unable to be sampled accurately with the rhythmia hdx mapping system.The orion was exchanged for an intellanav mifi oi ablation catheter and ablation was attempted in the inferior septal lv.Magnetic tracking of the ablation catheter was limited to areas distant from the vad cannula, and could not be visualized when placed within approximately 5cm of the cannula.The procedure was terminated due to inability to localize catheters in required locations and because the patient was frequently going into ventricular fibrillation and was becoming difficult to defibrillate.No other adverse events occurred.

• 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: 8495572
• MDR Text Key: 141335528
• Report Number: 2134265-2019-03657
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• 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
• Date Manufacturer Received: 03/12/2019
• 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 OI ABLATION CATHETER; RHYTHMIA HDX MAPPING SYSTEM
• Patient Outcome(s): Required Intervention