INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER 87035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER 87035 manufactured by Boston Scientific Corporation.

Event Text Entries

[187706589] 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.
Patient Sequence No: 1, Text Type: N, H10


[187706590] It was reported that the patient experienced tissue damage. After an premature ventricular ectopy ablation procedure with an intellamap orion high resolution mapping catheter, the patient experienced a mediastinal thermal injury post ablation. During the procedure, radiofrequency (rf) ablation was delivered to the distal coronary sinus (cs) and the adjacent right ventricular outflow tract (rvot). There were no issues during the procedure. Upon discharge, the patient reported chest pain and a computed tomography (ct) chest scan was performed. A mediastinal thermal injury was reported. The orion catheter was left in the descending aorta during ablation. The catheter was disposed of and was therefore not being returned. No device performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03941
MDR Report Key9885062
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-02-20
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-08-08
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTIMOTHY DEGROOT
Manufacturer Street4100 HAMLINE AVENUE NORTH DC A330
Manufacturer CitySAINT PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6515826168
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street302 PARKWAY, GLOBAL PARK
Manufacturer CityLA AURORA - HEREDIA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Product CodeDRF
Date Received2020-03-26
Model Number87035
Catalog Number87035
Lot Number0024235946
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

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