FDA.reportPublic FDA data

MAUDE MDR 9888499

MDR report key
9888499
Report number
2134265-2020-03744
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEMSYSTEM, APPENDAGE CLOSURE, LEFT ATRIALBOSTON SCIENTIFIC CORPORATIONNGV10371103710024541289R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2701. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THERE WAS AN AIR EMBOLISM. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND A 33MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE CLOSURE DEVICE WAS DEPLOYED IN THE LAA OF THE PATIENT. AT THIS TIME THE PHYSICIAN NOTED THAT THERE WAS AIR BEHIND THE DEVICE. THE AIR BUBBLE WERE RELIEVED/BROKEN UP AND THE PROCEDURE WAS CONTINUED. THE CLOSURE DEVICE MET RELEASE CRITERIA AND WAS SUCCESSFULLY IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT OCCURRED AND THE PATIENT WAS DOING FINE.