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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed.A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) was used.The closure device was deployed, but was too distal, so a partial recapture was performed and no pericardial effusion was noted.The closure device was deployed a second time, but failed the tug test.It was then fully recaptured and removed from the patient.There was no effusion noted.A non-bsc pigtail catheter was reinserted into the laa and an effusion was noticed.Pericardiocentesis was performed and 700cc blood was removed and given back to the patient.Once the effusion and patient stabilized, the procedure continued and a 24mm watchman laa closure device was successfully implanted.The patient was given protamine and the drain was left in place.The patient was transferred to the intensive care unit.The drain was removed two days post procedure and the patient went to a step down unit in stable condition.The physician believes the perforation occurred on the full recapture and was not noticed until the pigtail was re-inserted.

• 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: 10727824
• Report Number: 2134265-2020-13928
• Device Sequence Number: 3457447
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/23/2020

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: 01/14/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025043649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention