MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10373
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	08/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned.The first 24mm closure device was deployed too proximal and a full recapture was performed with no effusion noted.The physician changed the was and a new 24mm device was prepped.The pigtail was removed but the device was unable to obtain bleed back.However, the was was moved proximal until blood was attained with no effusion noted.Due to the proximal location of the sheath, the pigtail was re-inserted to get back in position.The physician injected contrast that revealed the pigtail to be outside the back wall of the laa.No effusion was noted on transesophageal echocardiography (tee).The physician pulled everything proximal and a small effusion was noted.Additionally, the patient became hypotensive.A pericardiocentesis was performed and approximately 1000ml of fluid was removed and protamine was given.The patient was taken to ct surgery and atrial clip was performed.The patient was extubated and discharged.

• Brand Name: WATCHMAN ACCESS 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: 10519185
• Report Number: 2134265-2020-12602
• Device Sequence Number: 14216778
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: 11/12/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0024759996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention