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	12/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus occurred.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.Upon advancing the was and pigtail catheter, a thrombus was noted to be wrapped around the tip of the pigtail.The physician attempted to aspirate the clot, but was unsuccessful.At this time, the pigtail was pulled in the was and the clot was successfully retrieved.The procedure continued and the closure device was successfully implanted without further complication.No adverse patient events were reported.Patient is stable and has been 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: 9553495
• Report Number: 2134265-2019-16380
• Device Sequence Number: 11613769
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 01/06/2020

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: 09/10/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0024411675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR