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

Model Number	TU-8001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion (pe) occurred.A left atrial appendage (laa) closure procedure was being performed.Prior to the procedure, a trace pe was noted.A versacross connect system was utilized for trans-septal puncture (tsp).The physician crossed the septum posteriorly and mid.After crossing the septum, the physician was unable to see the watchman fxd curve access system (was) sheath in the left atrium (la) due to imaging and small size of the la.Additionally, the physician was unable to get the pigtail into the laa.The physician pulled everything back into the right atrium (ra) with plan to perform a more optimal tsp.The pre-existing trace pe was evaluated and appeared to be unchanged.Tsp was evaluated and appeared to be posterior and angled posterior in the septum.The physician waited 4 minutes to monitor the baseline trace pe, and again, it appeared to be unchanged.Physician attempted to re-perform tsp.When dropping down to evaluate the tenting, the pe was noted to be growing along the ra to the right ventricle and left ventricle.The patient was stable, however the physician decided to cancel the procedure out of caution.Heparin was reversed and the patient was monitored.The patient was discharged same day.The physician suspects the was sheath may have hit the posterior wall while crossing the septum.

• Brand Name: WATCHMAN FXD CURVE ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17261659
• Report Number: 2124215-2023-32843
• Device Sequence Number: 7911732
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: 00191506013806
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 07/05/2023

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: 08/16/2025
• Device Model Number: TU-8001
• Device Catalogue Number: TU-8001
• Device Lot Number: 0029970348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female