MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a device leak occurred.A left atrial appendage (laa) closure procedure was performed and a 33mm watchman laa closure device was implanted.Multiple devices were attempted to close the laa due to a complex anatomy but no adverse events took place.At the 3-month transesophageal echo (tee) follow-up, a visible lobe was uncovered that measured 10-11mm.On (b)(6) 2021, the patient was brought back to occlude the exposed inferior lobe next to the implanted 33mm device.A 20mm non-boston scientific plug was attempted first under echo and fluoroscopy guidance but it was too large.They then used an 18mm non-boston scientific plug which successfully occluded the exposed lobe and was deployed.An effusion started to develop post-deployment but there were no signs of cardiac tamponade.The effusion measured 1.8cm-2.0cm so a pericardiocentesis was performed to treat the effusion.Approximately 500-600ml of blood was removed and a drain was placed.The effusion was no longer visible on tee and transthoracic echo (tte).The patient stayed overnight and the drain was removed the following morning.No other adverse events took place and the patient was stable.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY 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: 11350767
• Report Number: 2134265-2021-01942
• Device Sequence Number: 4117731
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023835988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1