INTELLANAV MIFI OPEN-IRRIGATED 87047

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-13 for INTELLANAV MIFI OPEN-IRRIGATED 87047 manufactured by Boston Scientific Corporation.

Event Text Entries

[183321331] It was reported that a catheter leak occurred. During an cardiac ablation procedure to treat idiopathic ventricular tachycardia in the left ventricle an intellanav mifi open-irrigated catheter was selected for use. It was noted that the generator had reached 40 degrees celsius and a high temperature error message was observed after several ablation attempts. It was also noted that the catheter was leaking irrigation fluid from the tubing connected to the catheter handle. The procedure was completed by replacing the catheter with another of the same model. No patient complications were reported and the patient's current condition is fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03226
MDR Report Key9829259
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-13
Date of Report2020-03-13
Date of Event2020-02-14
Date Mfgr Received2020-02-14
Device Manufacturer Date2019-07-24
Date Added to Maude2020-03-13
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 NameINTELLANAV MIFI OPEN-IRRIGATED
Generic NameCATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Product CodeOAD
Date Received2020-03-13
Returned To Mfg2020-02-28
Model Number87047
Catalog Number87047
Lot Number0024160973
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-13

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