MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a perforation occurred.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 selected to be used.During the procedure it was noted that there was a tear in the left lower pulmonary vein.The patient was taken to surgery where the tear was fixed and the laa was clipped.The patient was doing well and recovering from these events.

Event Description

It was reported that a perforation occurred.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 selected to be used.During the procedure it was noted that there was a tear in the left lower pulmonary vein.The patient was taken to surgery where the tear was fixed and the laa was clipped.The patient was doing well and recovering from these events.It was further reported that the patient lost 3l of blood as a result of the tear from the manipulation of the was.The patient did make a full recovery and they are now off of anticoagulation medication.

Manufacturer Narrative

E1: initial reporter address 1 - (b)(6).

• Brand Name: WATCHMAN ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10569796
• MDR Text Key: 208017969
• Report Number: 2134265-2020-12908
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other