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	12/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a perforation.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was used and a watchman laa closure device & delivery system (wds) was selected to be used.It was reported that the was was introduced into the body and placed in the laa using a pigtail.Once the physician was at the depth that was required for the device, the physician removed the pigtail.When this was done the sheath jumped forward and perforated the left atrial appendage.The physician called the surgeon in to evaluate.At this time, there was no effusion noted.The surgeon felt it was best to clip the laa and surgically repair the perforation.The patient was prepped and the surgery was completed successfully.The patient is stable and recovering well.The watchman procedure was not finished, no implantation of the device occurred.

• Brand Name: WATCHMAN 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: 8172337
• Report Number: 2134265-2018-63815
• Device Sequence Number: 2069667
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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: 07/29/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0022442880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention