MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device failure to seal and suspected implant fabric damage occurred.In (b)(6) 2019, a left atrial appendage (laa) closure procedure was performed using a 27mm watchman laa closure device with delivery system (wds).In (b)(6) 2023 during a transesophageal echocardiogram (tee) for a pulmonary hypertension follow up examination, a 2mm peri device leak was noted.The fabric of the closure device showed visible surface discontinuity and flow was noted into the laa through the closure device.No patient complications were reported.
Event or Problem Description
It was reported that a device failure to seal and suspected implant fabric damage occurred.In (b)(6) 2019, a left atrial appendage (laa) closure procedure was performed using a 27mm watchman laa closure device with delivery system (wds).In (b)(6) 2023 during a transesophageal echocardiogram (tee) for a pulmonary hypertension follow up examination, a 2mm peri device leak was noted.The fabric of the closure device showed visible surface discontinuity and flow was noted into the laa through the closure device.No patient complications were reported.It was further reported three days post index procedure the patient was discharged on warfarin.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16388746
• Report Number: 2124215-2023-06521
• Device Sequence Number: 5605582
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 05/10/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023776289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2019
• 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: 72 YR
• Patient Sex: Male