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

Model Number	M635TU70010
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Extravasation (1842); Hematoma (1884); Pain (1994); Vascular Dissection (3160)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was enrolled in the champion-af study on (b)(6) 2021 with patient identifier (b)(6).Prior to the index procedure, aspirin (81mg) and apixaban (10 mg) was administered.A left atrial appendage (laa) closure procedure was being performed.The trans-septal puncture (tsp) was performed and a watchman truseal access system (was) was advanced.However, through assessment via transesophageal echocardiogram (tee) and intraoperative angiography, there were no suitable was sheath alignments to the laa ostium.The procedure was aborted.Tee confirmed there were no acute thrombus in the laa.It was reported that a second was was used during this attempt, but no further details are known.On the same day, post-procedure attempt, while in recovery, the patient experienced severe pleuritic back pain and right flank pain.The patient was admitted to the hospital.Urgent bedside echocardiography was performed which revealed there was no pericardial effusion.The patient was treated with a dose of toradal and benadryl for a possible protamine reaction.Chest computerized tomography angiography (cta) with contrast revealed a large circumferential hematoma and active extravasation thinning from the medial aspect of the descending aorta with a probable dissection or aortic injury noted.A vascular surgeon was consulted who felt the aortic dissection may have been incidental and the bleeding was venous.The hematoma was suspected from the inferior vena cava (ivc) and active extravasation was noted.The physicians suspected that a possible perforation of the ivc may have occurred during the tsp.The patient's pain rapidly improved.One day post-procedure attempt, chest cta revealed a decrease in hematoma size.No extravasation was noted.No evidence of aortic injury was identified.Two days post-procedure attempt, chest cta revealed the hematoma to decrease further.No extravasation was noted and the ivc appeared normal.No dissection or aneurysms were noted.Three days post-procedure attempt, the patient was discharged from the hospital.No additional information is known at this time.

• Brand Name: WATCHMAN 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
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12908469
• Report Number: 2134265-2021-15092
• Device Sequence Number: 4081123
• Product Code: NGV
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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: 05/30/2024
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0027407450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Race: White