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	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	05/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: bsc aware date used as event date is unknown.
Event or Problem Description
The following event originated from social media, and therefore despite good faith efforts the information is often incomplete.Additionally, due to the limited information received through good faith efforts, this event may represent a duplicate of an event which was already known to boston scientific.It was reported that pericardial effusion occurred.A left atrial appendage closure procedure was performed, and a watchman flx closure device was implanted.At an unspecified time, post-discharge, the patient was transferred via ambulance to the same hospital that the implant procedure took place.The patient was brought to the catheterization laboratory and the patient's blood pressure was not registering.A pericardial effusion was identified and a pericardiocentesis was performed.The patient is doing well now with no further complications and is off their xarelto.
Additional Manufacturer Narrative
B3: event date corrected from (b)(6) 2023 to (b)(6) 2020 based on additional information.B5: additional information.D4: model number, lot number, catalog number, expiration date, udi# added.D6a: procedure date added.H4: manufacture date added.
Event or Problem Description
The following event originated from social media, and therefore despite good faith efforts the information is often incomplete.Additionally, due to the limited information received through good faith efforts, this event may represent a duplicate of an event which was already known to boston scientific.It was reported that pericardial effusion occurred.A left atrial appendage closure procedure was performed, and a watchman flx closure device was implanted.At an unspecified time, post-discharge, the patient was transferred via ambulance to the same hospital that the implant procedure took place.The patient was brought to the catheterization laboratory and the patient's blood pressure was not registering.A pericardial effusion was identified and a pericardiocentesis was performed.The patient is doing well now with no further complications and is off their xarelto.It was further reported that the patient was transferred via ambulance back to the hospital the day after the procedure.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18068395
• Report Number: 2124215-2023-61046
• Device Sequence Number: 7593689
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: 08/29/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024352959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male