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

Model Number	10371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 30mm watchman laa closure device & delivery system (wds) were used.After gaining depth in the laa and removing the pigtail catheter from the was the device was loaded into the was.Once the device was about 75% in the sheath it was noted that the sheath had move forward and appeared to be outside of the laa.They swept for an effusion using transesophageal echo (tee) and no effusion was appreciated.Contrast was then used and it was noted that some contrast was flowing outside the appendage.The device was quickly deployed and release criteria was assessed and met.The device was released.The patient's blood pressure began to drop and an effusion was noticed to be about 1cm on tee.A pericardiocentesis was performed and 350ml was drawn from the space.It was immediately delivered back through the was.Heparin was reversed and the effusion minimized.The patient's blood pressure remained low after giving 3l of fluid.Two units of blood were given.The patient's blood pressure stabilized and the patient was extubated and sent to the icu for observation.The patient is expected to make a full recovery but has not been discharged as of yet.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10942903
• Report Number: 2134265-2020-16657
• Device Sequence Number: 19641026
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025355440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention