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

Model Number	10373
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a kink and pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system and two watchman laa closure device and delivery systems were used.A pericardial effusion was noted at baseline around the right atrium (ra) and right ventricle (rv).It was noted that the baseline effusion around the ra had grown slightly after a very difficult transeptal puncture, but the patient was stable.A 33mm watchman laa closure device was deployed, but was proximal.Therefore, a full recapture was performed and effusion was noted to be stable.A 30mm watchman laa closure device was attempted next.The device landed slightly deep and a partial recapture was performed.It was noted that the device was hooked on the appendage wall.During a recapture attempt the access system kinked at the dark-light blue transition and there was a struggle to pull the feet of the device into the access system due to the large kink.A kink was also noted in the delivery system.Proactively, a pericardial drain was put in and 100ccs was drained.The 30mm device was successfully recaptured and the effusion was noted to be stable.Another access system and 30mm closure device were attempted, but the closure device landed canted.The decision was made to fully recapture the device and abort the case.Additional fluid was drained and the patient was transferred to critical care unit stable with the drain in place.

• Brand Name: WATCHMAN ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11749432
• Report Number: 2134265-2021-05469
• Device Sequence Number: 3856364
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025263452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR