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

Model Number	M635TU70040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/08/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient death occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned and a 31mm watchman flx laa closure device & delivery system (wds) were used.The physician was having a challenging time getting venous access.A 16fr x 13 cm length non-boston scientific (bsc) introducer sheath was placed over a standard j-wire.It was noted this did not go smoothly.The dilator was removed and then reintroduced to reposition the sheath.Radiography showed the dilator was not in the lumen of the sheath.Both were removed and replaced.The non boston scientific introducer sheath demonstrated a perforation from the dilator of the transseptal puncture (tsp) sheath.The non-bsc guidewire buckled/bent and the tsp sheath perforated through the non-bsc introducer sheath and, subsequently, through the femoral vein.The procedure continued with a new 16 fr sheath being placed.The watchman procedure was completed successfully with the closure device implanted in the laa of the patient.The patient became hemodynamically unstable after the procedure, while still in the room.No pericardial effusion was present.The patients groins were evaluated and a hematoma was noted.Vascular surgery was called in and an angiogram showed that there was an iliac vein perforation.A covered stent was placed and the patient was moved to the intensive care unit.While in the intensive care unit the patient continued to bleed.The patient had disseminated intravascular coagulation and went into hypovolemic shock.The family of the patient decided to remove care for the patient and the patient ultimately passed away.

• 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: 12242638
• Report Number: 2134265-2021-09226
• Device Sequence Number: 3718909
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/28/2021

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: 03/21/2024
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0027006955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 67 YR