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 Code	Pericardial Effusion (3271)
Date of Event	12/16/2020
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.The laa was an anterior chicken wing.A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The was was placed within the laa with use of a pigtail catheter.The 21mm device was prepped and the pigtail catheter was removed.The wds was inserted into the was and advanced to the distal marker band.The physician snapped back left to right to connect the was to the wds.A puff of contrast showed that the wds was in the pericardium.The physician pulled the whole system back within the laa (confirmed with contrast) and deployed the 21mm watchman device.Initially, the transesophageal echocardiogram (tee) showed the device to be positioned well so a tug test was performed.During this time the patient was stable.The tee prior to access showed a small effusion.The device was assessed by echocardiogram and met release criteria and was released.The activated clotting time (act) was 340 and protamine was given.The whole system was pulled out of the body and the groin site was closed via two non-boston scientific devices.The patient was monitored on tee for 20 minutes.The effusion grew to about 1cm and the patient remained stable.A pericardiocentesis was performed and 210cc of blood was drained and the drain was sutured in place.The drain was left in overnight.

• 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: 11110174
• Report Number: 2134265-2020-18337
• Device Sequence Number: 14354671
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 01/04/2021

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: 01/21/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025080273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR