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 Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Thrombosis (2100); Pericardial Effusion (3271)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer: 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
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A transeptal puncture was performed and an unspecified guide wire was placed in the left atrium and upper pulmonary vein.Then a watchman ® access system was advanced, but never entered the laa.At this time the patient¿s blood pressure started to drop, which may have been caused by a perforation which let to a pericardial effusion.A pericardiocentesis was performed.The patient was monitored for a couple of hours on the table and was then sent to holding.While in holding, the patient decompensated further; their blood pressure dropped.An attempt was made to withdraw fluid from the pericardium, but there was clot inside of the pericardial drain sheath.A pericardial window was cut to relieve the pressure.The patient is currently doing well and stable.There was no watchman device implanted.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7717622
• Report Number: 2134265-2018-06440
• Device Sequence Number: 1329044
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/26/2018

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: 11/19/2020
• Device Model Number: M635TU10060
• Device Catalogue Number: TU1006
• Device Lot Number: 21407670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/25/2018
• 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