WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371

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 2020-03-26 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371 manufactured by Boston Scientific Corporation.

Event Text Entries

[187706858] It was reported that a perforation and a pericardial effusion occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used. At baseline there was no pericardial effusion noted. After taking a picture of the left atrial appendage the pigtail catheter was removed and the wds was inserted. Once the device was snapped together a contrast picture was taken to check placement in the appendage. With this contrast picture it was noted that a perforation of the back of the appendage had occurred and contrast was flowing into the pericardium. The patient was hemodynamically stable so the device was assessed to ensure meeting pass criteria. Once pass criteria was assessed the device was released, the sheath was pulled back and protamine was given. The patient stayed hemodynamically stable throughout this entire process. There was a minor change in pericardial effusion but not large enough to need intervention. The patient was discharged the next day with no further complications or intervention needed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03798
MDR Report Key9886492
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-05-29
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 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 LAA CLOSURE DEVICE & DELIVERY SYSTEM
Generic NameSYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Product CodeNGV
Date Received2020-03-26
Model Number10371
Catalog Number10371
Lot Number0023867060
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
10 2020-03-26

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