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	10/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned.When the was was inserted into the body there was a blood clot in the tip of the sheath.The physician removed the device, flushed the device and checked to ensure the activated clotting time (act) was within adequate range.The act was within an adequate range as it was between 275-358.After performing all this the was reinserted into the patient.Once again the blood clotted around the sheath.The physician removed the device and replaced it with a new was.The second was had no issues and the procedure was completed without any further complications.The patient is 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: 8083920
• Report Number: 2134265-2018-62938
• Device Sequence Number: 1332202
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 11/19/2018

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: 12/19/2020
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0021535403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other