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 Code	Pericardial Effusion (3271)
Date of Event	01/21/2020
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 27mm watchman laa closure device & delivery system (wds) were used.The physician positioned the was into the appendage and advanced the wds into the sheath all the way up to the distal end.Right before the closure device was ready to deploy, the physician shot a little bit of contrast just to confirm position and noted that there was a pericardial effusion.The procedure was continued with no treatment for the pericardial effusion.The closure device was successfully implanted in the laa of the patient.The physician monitored the effusion, which did not get any worse and actually subsided.Protamine reversal was given, but no further intervention was needed.The physician did not have to do anything, they just monitored it and it did not worsen.Protamine reversal was the only step they took towards correcting it.The patient remained stable and was doing fine.

• 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: 9673873
• Report Number: 2134265-2020-00946
• Device Sequence Number: 2913459
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/05/2020

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: 03/03/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023433134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR