FDA.reportPublic FDA data

MAUDE MDR 9888900

MDR report key
9888900
Report number
2134265-2020-03769
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 ACCESS SYSTEMSYSTEM, APPENDAGE CLOSURE, LEFT ATRIALBOSTON SCIENTIFIC CORPORATIONNGV10366103660024719737R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

Event Narratives#

D

Patient 1

IT WAS REPORTED A KINK AND RECAPTURE DIFFICULTY OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEM (WDS) WERE USED. THE CLOSURE DEVICE WAS DEPLOYED, BUT DID NOT MEET THE RELEASE CRITERIA, SO IT NEEDED TO BE RECAPTURED. DURING THE RECAPTURE, THE SHEATH OF THE WAS BECAME KINKED, SO THERE WAS NOT ENOUGH SUPPORT TO FULLY RECAPTURE THE CLOSURE DEVICE. ONLY HALF OF THE CLOSURE DEVICE WAS ABLE TO BE RECAPTURED INTO THE WAS. THEY WERE UNABLE TO REMOVE THE DEVICES IN AN INTERVENTIONAL WAY, SO THE PATIENT REQUIRED OPEN HEART SURGERY TO REMOVE THE DEVICES.