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

Model Number	M635TU70020
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	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was attempted using a watchman truseal access system (was).During the transseptal puncture and the was crossing the interatrial septum a pericardial effusion (pe) was discovered.The pe increased in size and the patient became hypotensive.After a pericardial drain was placed, blood was recirculated to the patient.The activated coagulation time (act) of the patient was 368 seconds at this point in the procedure.720ml of blood was drained and protamine was administered.Following administration of protamine an additional 180ml of blood was drained.After this additional blood was drained the act of the patient was 116 seconds.A further 10ml of blood was drained and the laa closure procedure was aborted.At an unspecified time following the procedure a pericardial window was placed.Six days post index procedure the patient fully recovered and was discharged.
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was attempted using a watchman truseal access system (was).During the transseptal puncture and the was crossing the interatrial septum a pericardial effusion (pe) was discovered.The pe increased in size and the patient became hypotensive.After a pericardial drain was placed, blood was recirculated to the patient.The activated coagulation time (act) of the patient was 368 seconds at this point in the procedure.720ml of blood was drained and protamine was administered.Following administration of protamine an additional 180ml of blood was drained.After this additional blood was drained the act of the patient was 116 seconds.A further 10ml of blood was drained and the laa closure procedure was aborted.At an unspecified time following the procedure a pericardial window was placed.Six days post index procedure the patient fully recovered and was discharged.It was further reported the patient recovery took place in the intensive care unit.

• 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: 15330063
• Report Number: 2124215-2022-32534
• Device Sequence Number: 5374847
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 01/24/2023

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: 02/21/2025
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0028918749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White