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	10/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a thrombus on the tip of the access system.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 used.The physician positioned the was in the laa of the patient and opened the hemostatic valve, but observed no blood back flow.The physician checked for kinks and aspirated with no back flow still.The physician then checked the echocardiogram imaging and noted that there was a thrombus on the tip of the was.The physician aspirated the thrombus back into the was and then removed the was from the patient.The physician used a new was to deploy the closure device in the laa of the patient.This device did not meet release criteria and due to the patient anatomy the procedure was ended without implanting a device.The patient is doing fine following these events and no other complications were reported to have occurred.
Additional Manufacturer Narrative
The returned product consisted of a watchman access system.The device was bloody.Analysis of the tip, sheath and hub/valve included microscopic and visual inspection.Inspection found no damage or defect with the returned device.The reported thrombus was not confirmed.
Event or Problem Description
It was reported that there was a thrombus on the tip of the access system.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 used.The physician positioned the was in the laa of the patient and opened the hemostatic valve, but observed no blood back flow.The physician checked for kinks and aspirated with no back flow still.The physician then checked the echocardiogram imaging and noted that there was a thrombus on the tip of the was.The physician aspirated the thrombus back into the was and then removed the was from the patient.The physician used a new was to deploy the closure device in the laa of the patient.This device did not meet release criteria and due to the patient anatomy the procedure was ended without implanting a device.The patient is doing fine following these events and no other complications were reported to have occurred.

• 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: 10717784
• Report Number: 2134265-2020-14181
• Device Sequence Number: 3141078
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 11/02/2020

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: 02/03/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025151852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/02/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR