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

Model Number	M635TU80010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the access system became kinked.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a 20mm watchman flx laa closure device & delivery system (wds) were selected to be used.The physician positioned the double curve was in the laa of the patient and then inserted the wds.The closure device was deployed three (3) times but did not meet release criteria.The physician decided to replace the was with a new single curve was.The new was positioned in the laa, and the physician then deployed a new 24mm closure device.The closure device was deployed four (4) times but did not meet release criteria.During one of the deployments the was became kinked.The physician decided to continue the procedure using the kinked was.A new 20mm closure device was then deployed twice in the laa of the patient.During the second deployment fluoroscopy imaging showed that the system shifted inside the patient and perforated the laa.The perforation resulted in a pericardial effusion.The physician performed a pericardiocentesis draining one (1) liter of bright red blood which was then given back to the patient.The patient underwent open heart surgery where the effusion was resolved and the laa of the patient was ligated.There were no other complications that were reported to have occurred, and the patient is expected to make a full recovery.

• 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: 21126916
• Report Number: 2124215-2025-00482
• Device Sequence Number: 15372935
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: 00191506013806
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212228
• 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): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635TU80010
• Device Catalogue Number: M635TU80010
• Device Lot Number: 0033780776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 04/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Race: White