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

Model Number	M635TU10060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-05152.It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman® access system (was) was positioned at the deepest part of the laa that could be safely reached and a 21mm watchman ® laa closure device & delivery system (wds) was advanced.The closure device was deployed in the laa and shortly after deployment, the echocardiographer noticed a growing pericardial effusion.A pericardiocentesis was performed to extract fluid from the pericardium.The patient was stabilized and the closure device was implanted and released from the core wire.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7577233
• Report Number: 2134265-2018-05153
• Device Sequence Number: 2629738
• 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): 05/17/2018

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: 10/31/2020
• Device Model Number: M635TU10060
• Device Catalogue Number: TU1006
• Device Lot Number: 0021325772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention