MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number 10371

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 11/04/2020

Event Type  Injury  

Event Description

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 27mm watchman laa closure device & delivery system (wds) were used.This device was removed as it was noted to be too small.A 33mm device was then used and the sheath dropped from the anterior lobe to the posterior lobe.During device deployment, the feet of the device was clearly seen in the pericardial space through the laa.The case was stopped and the device was removed from the patient.The patient was given protamine.The patient was confirmed to have a 6mm effusion.The patient was sent to icu to be monitored and no further intervention was required.The patient was stable and has been discharged.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10887855
• MDR Text Key: 217919685
• Report Number: 2134265-2020-15781
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023343433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR