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

Model Number	10373
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: (b)(6).
Event or Problem Description
It was reported air embolism occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned in the laa and immediately air was noticed within the was.The air entered the patient, but was able to be aspirated from the laa.The was removed and they exchanged for another was to complete the procedure successfully.Once it was removed from the patient, they noticed the hemostasis valve on the was had a leak which introduced the air.There were no patient complications.The patient had no neurological deficits and is fine.
Event or Problem Description
It was reported air embolism occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned in the laa and immediately air was noticed within the was.The air entered the patient, but was able to be aspirated from the laa.The was was removed and they exchanged for another was to complete the procedure successfully.Once it was removed from the patient, they noticed the hemostasis valve on the was had a leak which introduced the air.There were no patient complications.The patient had no neurological deficits and is fine.
Additional Manufacturer Narrative
Age at time of event: 80 years.Device evaluated by mfr: returned device consisted of a watchman access system with the dilator snapped into the sheath.Analysis of the tip, sheath and hub/valve included microscopic and visual inspection.Inspection found no damage or defects with the returned device.The was functionally tested by attaching a syringe (filled with water) to the hub/valve.The valve was closed shut and positive pressure was applied to the device, and then was also opened and flushed.This test was performed 3 times, and each time the device functioned in the expected fashion, with no additional air in the system, and the device did not leak.

• 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: 8932784
• Report Number: 2134265-2019-09823
• Device Sequence Number: 11249822
• 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,Followup
• Report Date (Section B): 10/01/2019

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: 03/10/2022
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023468941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 10/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention