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	08/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus occurred.A watchman access system (was) anterior curve and watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.After the trans-septal puncture was performed and the was in the patient, a thrombus was noted in the right atrium and more heparin was administered.A total of 23,000 units of heparin was given during the procedure with an activated clotting time (act) of 230.Procedure was successfully completed.Patient remained stable without signs of stroke.Thrombus was still seen at the end of the procedure.Patient was discharged and will follow recommended anti-coagulation post implant therapy per physician.

• 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: 8941299
• Report Number: 2134265-2019-10306
• Device Sequence Number: 2521356
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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: 09/18/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0022675815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR