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/Thrombus (4440)
Date of Event	03/03/2021
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.A double curve watchman access system (was) was positioned and a 33mm watchman laa closure device & delivery system (wds) were used.After the transseptal puncture was performed and the was was placed across the septum, they noticed some object on the tip of the sheath or the non-boston scientific guidewire that was in the left atrium.The activated clotting time (act) was in the therapeutic range around 250 seconds.Aspiration was performed with a syringe on the was.They did not see any change on echo and the foreign body was still present.The guidewire was removed and as they retracted the guidewire they aspirated through the was.At the end of this maneuver the foreign body was not seen and the procedure continued.The device was successfully implanted and no further interventions were needed.The act remained above 300 seconds after the foreign body was seen.The patient was checked for any signs of stroke or transient ischemic attack and none were seen or noted by the physician.The patient is doing well with no further issues.

• 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: 11556343
• Report Number: 2134265-2021-03701
• Device Sequence Number: 17194541
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: 01/13/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025038662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other