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,foreig report with the FDA on 2020-03-26 for INTELLANAV MIFI OPEN-IRRIGATED 87047 manufactured by Boston Scientific Corporation.

Event Text Entries

[187707395] 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


[187707396] It was reported that the patient experienced a pericardial effusion. During a pulmonary vein isolation (pvi) ablation procedure with an intellanav mifi open-irrigated catheter to treat atrial fibrillation, pvi was nearly finished but the physician had problems reaching the anterior part of the right inferior pulmonary vein (ripv) ostium. He tried to maneuver the catheter to the desired spot several minutes, but could not get there. Resistance was felt when the physician tried to reach the anterior wall at ripv ostium. Another physician took over and realized that the catheter wasn't located in the left atrium anymore, but was withdrawn into the right atrium. Then, the blood pressure of the patient dropped and they discovered a pericardial effusion. They performed a pericardiocentesis, but the hole was closed within a few minutes and the patient's blood pressure was good again. After that the patient woke up, they were orientated and able to communicate. The patient fully recovered. The physician was convinced that the perforation happened because he did not realize that the catheter was in the right atrium, and tried to reach an anterior part of the left atrium. Therefore, he pushed too hard with the catheter within the non-boston scientific sheath and that made it really stiff and inflexible. It was not related to any malfunction of the catheter. The catheter was disposed of, and is therefore not available for return.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03926
MDR Report Key9884474
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-02-27
Date Mfgr Received2020-02-27
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 NameINTELLANAV MIFI OPEN-IRRIGATED
Generic NameCATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Product CodeOAD
Date Received2020-03-26
Model Number87047
Catalog Number87047
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 2020-03-26

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