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

Model Number	M635TU70010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study.It was reported that a vessel perforation and hematoma occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman flx laa closure device & delivery system (wds) were prepared.The was inserted through a 16f 40 centimeter sheath in the groin.After an initial fluoroscopy image was taken with the was and the pigtail catheter, the physician found the anatomy of the patient unsuitable for implantation.The anatomy was such that the implantable depth was at a right angle from the sheath approach.Two transseptal puncture locations were tried but neither provided access to properly implant the device.The sheath was removed and the patient was transferred to recovery.While in recovery the patient experienced chest pain.Scans revealed bleeding in the thoracic and abdominal cavities originating from the inferior vena cava.The patient was taken off anticoagulants and moved to the post anesthesia care unit for monitoring.The direct cause is unclear according to the physician; however, it was assumed that a vessel tear may have occurred while removing the sheaths.There were no further reported patient complications and the patient is expected to make a full recovery.

• 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
• MDR Report Key: 12647225
• Report Number: 2134265-2021-12971
• Device Sequence Number: 13806898
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: 03/25/2024
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0027038916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR