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 Codes	Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported procedural complications occurred.A left atrial appendage (laa) closure procedure was being performed.While gaining access at the groin, difficulty was noted during use of the transseptal sheath and a vascular access sheath was used to resolve the issue.Once access was gained, a double curve watchman access system (was) was advanced.The was could not be positioned properly in the laa and was therefore exchanged for a single curve was.At this time the physician noted that there were some ekg changes that indicated left bundle branch block and some fluctuations in the patients blood pressure.The physician imaged the femoral vein which revealed some seepage around an area where there was some tortuosity.The procedure was aborted.The patient was stable at the end of the case.There was no evidence of effusion.A vascular surgeon was consulted however it was determined no intervention was necessary.There were no further patient complications.

• 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: 9433648
• Report Number: 2134265-2019-14501
• Device Sequence Number: 14012648
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/06/2019

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: 03/10/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023468942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other