WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM 10390

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 2020-03-24 for WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM 10390 manufactured by Boston Scientific Corporation.

Event Text Entries

[184738853] (b)(6) study. It was reported a pericardial effusion with tamponade occurred. On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed. A 20mm watchman flx laa closure device was successfully implanted with a complete laa seal and deployed device diameter of 14. 0 mm. Five hours post procedure, the patient experienced pericardial effusion with cardiac tamponade and a perforation was noted. A pericardiocentesis was performed to resolve the pericardial effusion. The event was considered resolved on (b)(6) 2020. On (b)(6) 2020, the patient was discharged to another hospital.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03746
MDR Report Key9871823
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-26
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-03-14
Date Added to Maude2020-03-24
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
Generic NameSYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Product CodeNGV
Date Received2020-03-24
Model Number10390
Catalog Number10390
Lot Number0023489738
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-24

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