EP XT 86716

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-25 for EP XT 86716 manufactured by Boston Scientific Corporation.

Event Text Entries

[187083775] 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


[187083776] (b)(6) clinical study. It was reported that the patient experienced pneumonia, "cardial decomposition," pain in the lower stomach, ascites and pleural effusion following an ablation procedure with an intellanav mifi open-irrigated ablation catheter, an intellamap orion high resolution mapping catheter, a tsx fixed curve sheath, an ep-xt diagnostic catheter and a non-boston scientific steerable introducer. The patient was given intravenous or intramuscular antibiotics and the event resolved. The suspected cause was exertional dyspnea after ablation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03868
MDR Report Key9878896
Report SourceFOREIGN,HEALTH PROFESSIONAL,S
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-01-21
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-06-28
Date Added to Maude2020-03-25
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 NameEP XT
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Product CodeDRF
Date Received2020-03-25
Model Number86716
Catalog Number86716
Lot Number0024030903
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. Required No Informationntervention 2020-03-25

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