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	Perforation (2001); Pericardial Effusion (3271)
Date of Event	05/23/2018
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
Same case as mfr: 2134265-2018-05516.It was reported that a and a perforation with subsequent pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed.The watchman® access system (was) was deep seated in the laa.A 24 mm watchman ® laa closure device and delivery system (wds) was then advanced.After the closure device was deployed, the closure device was partially recaptured due to a gap that needed to be repositioned.Then an echocardiogram revealed a puncture which led to a pericardial effusion.The patient did not experience cardiac tamponade, or changes in their status.The closure device was fully recaptured and another 24 mm wds was inserted and deployed to slow the pe down.A pericardiocentesis was then performed.They left the 2nd 24 mm closure device in place; however, the patient went to surgery to suture a hole at the tip of the appendage.The patient was extubated, talking, and was doing fine.They will be discharged once a pacer procedure has been performed.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7583721
• Report Number: 2134265-2018-05259
• Device Sequence Number: 13948094
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/23/2018

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: 01/25/2021
• Device Model Number: M635TU10060
• Device Catalogue Number: TU1006
• Device Lot Number: 0021662383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/08/2018
• 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