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); Nausea (1970); Pericardial Effusion (3271)
Date of Event	05/02/2018
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: 2134265-2018-05388.It was reported that pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed.Imaging on transesophageal echocardiogram (tee) was very hazy and transseptal crossing was noted to be very difficult.A watchman® access system (was) was used with a 21 mm watchman ® laa closure device & delivery system (wds).The closure device was deployed and released without issue.About 4 hours post procedure, the patient started experiencing symptoms of nausea and became hypotensive.They tried treating the symptoms with medication.The physician then performed a transthoracic echocardiogram and noticed that there was a small pericardial effusion.The patient returned to the lab and pericardiocentesis was performed; approximately 200-250 cc of fluid was extracted.After this, the patient's symptoms began to improve and the patient was discharged without harm.It was noted that the implanting physician believed the symptoms post procedure could have also been related to the patient¿s gastrointestinal bleeding issues in conjunction with the heparin given during the case.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7574186
• Report Number: 2134265-2018-05387
• Device Sequence Number: 11119046
• 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): 05/09/2018

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: 01/18/2021
• Device Model Number: M635TU10060
• Device Catalogue Number: TU1006
• Device Lot Number: 0021633225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• 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