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 2020-03-23 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371 manufactured by Boston Scientific Corporation.

Event Text Entries

[184480660] It was reported that a cardiac perforation and pericardial effusion occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used. The was was positioned in the laa. The location of the feet of the 27mm wds was checked by cine prior to alignment of the distal marker bands. Upon alignment, when the wds was being snapped into place, a significant jump was observed. Contrast was injected and an effusion sweep was conducted and contrast was seen going into the pericardial space and an effusion began to develop. A pericardiocentesis was performed to treat the pericardial effusion. The condition of the patient was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03163
MDR Report Key9865677
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-10-31
Date Added to Maude2020-03-23
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 Received2020-03-23
Model Number10371
Catalog Number10371
Lot Number0024688681
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 2020-03-23

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