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

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation occurred.A left atrial appendage (laa) closure procedure was being performed.While the physician was positioning the watchman access system (was) in the appendage of the patient they caused a slight perforation of the laa.The patient was brought to have open heart surgery to fix the perforation.During surgery the perforation was treated and the laa of the patient was clipped.The patient did well following these events and has since been discharged from the hospital.
Event or Problem Description
It was reported that a perforation occurred.A left atrial appendage (laa) closure procedure was being performed.While the physician was positioning the watchman access system (was) in the appendage of the patient they caused a slight perforation of the laa.The patient was brought to have open heart surgery to fix the perforation.During surgery the perforation was treated and the laa of the patient was clipped.The patient did well following these events and has since been discharged from the hospital.
Additional Manufacturer Narrative
It was reported that the physician caused a slight perforation of the laa during positioning of the was.As the physician perforated the laa, it was most likely that incorrect manipulation of the device occurred.So, it was considered likely the reported events occurred due to unintentional interaction and manipulation of the device.D3: manufacturer address 1, manufacturer city, manufacturer zip/postal code - updated g1: mfr contact first name, mfr contact last name, mfr contact address 1, mfr contact city, mfr contact zip/postal code, mfr contact phone number, mfr contact email - updated h6: impact codes - updated to include surgical intervention based on the event.H6: evaluation conclusion codes - updated from known inherent risk of device to unintended use error caused or contributed to event.

• Brand Name: WATCHMAN 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: 10769784
• Report Number: 2134265-2020-15055
• Device Sequence Number: 4089734
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• 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,Followup
• Report Date (Section B): 03/13/2024

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: 03/24/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025402726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown