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	09/03/2020
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 and a 24mm watchman laa closure device & delivery system (wds) were used.After the trans-septal was performed, the patient was administered 15,000 units of heparin.An activated clotting time (act) of 131 was reported ten minutes later.The physician asked for another act to be drawn and checked because the initial value was remarkably low for the amount of heparin given.Additional 3,000 units of heparin was administered.Subsequently, the physician successfully engaged the laa with the access sheath and deployed a 24mm closure device.A thrombus was noted to be forming on the was and wds as release criteria was being assessed.The anesthesiologist noted a large puddle of fluid and medication on the bed side of the patient and realized an issue or failure with the iv site.Eventually, it was discovered that the patient was unable to receive any heparin and additional 10,000 unit of boluses was successfully administered through the iv.The was and wds were monitored with no change to the thrombus.An act of 274 was drawn and a decision was made to release the closure device and aspirate the thrombus.Furthermore, the thrombus was confirmed on the edge of the access sheath.The wds sheath was removed while aspirating and the thrombus was successfully aspirated into the access sheath and removed from the patient.Additionally, a residual thrombus was noted in the right atrium near the interatrial septum.The patient woke up and was found to be responsive and able to follow commands.The patient had a neuro consult with no signs of stroke and was 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: 10600513
• Report Number: 2134265-2020-13431
• Device Sequence Number: 16886319
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/29/2020

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: 02/20/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025244206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention