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	11/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was being performed.9,000 units of heparin were administered prior to the transseptal puncture (tsp).No thrombus was seen in the left atrium.A watchman access system (was) was prepped and advanced into the laa.A contrast shot was given and an activated clotting time resulted at 80.Immediately thrombus was observed on echo at the tip of the sheath.The thrombus was aspirated and came back across the septum to the right side.At this time it was discovered the iv was not working.Another 5,000 units had been given just after the tsp.The patient was woken up for a neuro assessment and the exam was within normal limits.The case was aborted.There were no adverse effects to the patient.The patient will return in two weeks to reattempt implant.

• 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: 10942751
• Report Number: 2134265-2020-16658
• Device Sequence Number: 11570721
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/03/2020

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: 03/18/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025373557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other