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	Thrombosis (2100)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was thrombus in the sheath.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were selected for use.During the procedure, the physician had removed the dilator and was flushing the was when they discovered that there was a thrombus.The physician could not aspirate it out and decided to pull the entire sheath out of the patient.It was noted that the thrombus was inside of the was.There were no patient complications that resulted from this event.The patient was fine.A new was used to successfully complete the procedure.The patient has since been discharged from the hospital.

• 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: 9209156
• Report Number: 2134265-2019-12533
• Device Sequence Number: 447363
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/18/2019

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: 07/08/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0024074725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention