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	Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	05/08/2018
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: 2134265-2018-05110.It was reported a pericardial effusion and tamponade occurred.On (b)(6) 2018, a left atrial appendage (laa) closure procedure was performed.A watchman® access system and 33mm watchman ® laa closure device & delivery system were used.The closure device was deployed, but did not meet the release criteria.Therefore, it was fully recaptured and removed from the patient.It was exchanged for a 30mm watchman ® laa closure device, which was successfully implanted.There was no effusion noted on the echocardiogram.About two hours post procedure, a code blue was called on the patient because they went into cardiac arrest.There was no ekg strip documenting no rhythm.Chest compressions were performed and the code blue was cancelled.An echocardiogram was performed post chest compressions which noted a pericardial effusion and tamponade.About 800ml of fluid was tapped from the pericardium.The patient was doing better the next couple of days, but had a pleural effusion where one liter of fluid was tapped out.As days went on, the patient developed a hemothorax and three liters of fluid was tapped out.On (b)(6), the patient developed bradycardia with pulseless electrical activity (pea).Per the patient's wishes, no efforts were made to resuscitate the patient and the patient passed away.The cause of death was documented as bradycardia and pea.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7575064
• Report Number: 2134265-2018-05109
• Device Sequence Number: 1698721
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/08/2018

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: 03/07/2020
• Device Model Number: M635TU10060
• Device Catalogue Number: TU1006
• Device Lot Number: 0020375259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/06/2018
• 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
• Patient Age: 84 YR