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

Lot Number	0029377681
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.A pulmonary vein isolation (pvi) was performed.Following the completion of the pvi, a double curve watchman truseal access system (was) was placed in the groin.The intracardiac echocardiography (ice) catheter was moved, and the vasopressor levels increased from 0.08 to 0.16 within 30 minutes.An effusion check was performed with the ice catheter, and a pericardial effusion was noted.The pericardial effusion progressed to a cardiac tamponade.The procedure was aborted, and a pericardiocentesis was performed to drain the effusion.The patient was transferred to inpatient status and fully recovered from this event.
Additional Manufacturer Narrative
B5- describe event or problem - updated.
Event or Problem Description
It was reported that a cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.A pulmonary vein isolation (pvi) was performed.Following the completion of the pvi, a double curve watchman truseal access system (was) was placed in the groin.The intracardiac echocardiography (ice) catheter was moved, and the vasopressor levels increased from 0.08 to 0.16 within 30 minutes.An effusion check was performed with the ice catheter, and a pericardial effusion was noted.The pericardial effusion progressed to a cardiac tamponade.The procedure was aborted, and a pericardiocentesis was performed to drain the effusion.The patient was transferred to inpatient status and fully recovered from this event.It was further reported that the was was not fully inserted into the patient and there was approximately 4 inches remaining for complete placement.The closure device was never opened.
Additional Manufacturer Narrative
B5- describe event or problem - updated.
Event or Problem Description
It was reported that a cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.A pulmonary vein isolation (pvi) was performed.Following the completion of the pvi, a double curve watchman truseal access system (was) was placed in the groin.The intracardiac echocardiography (ice) catheter was moved, and the vasopressor levels increased from 0.08 to 0.16 within 30 minutes.An effusion check was performed with the ice catheter, and a pericardial effusion was noted.The pericardial effusion progressed to a cardiac tamponade.The procedure was aborted, and a pericardiocentesis was performed to drain the effusion.The patient was transferred to inpatient status and fully recovered from this event.It was further reported that the was was not fully inserted into the patient and there was approximately 4 inches remaining for complete placement.The closure device was never opened.It was further reported that the patient was rescheduled for another closure device implant in the following months.

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14915513
• Report Number: 2124215-2022-23296
• Device Sequence Number: 19340762
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2022

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: 05/10/2025
• Device Lot Number: 0029377681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 07/14/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/12/2022; 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Race: White