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

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus occurred.A watchman access system (was) single curve was positioned and a 24 mm watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.The was was positioned and prior to introducing the wds, the physician decided to exchange the single curve was for a double curve.At this time, the physician removed the device from the laa and introduced the pigtail catheter.Prior to inserting the new was, a large thrombus was noted just distal to the ostium of the laa.Immediately, the single curve was was removed from the patient and the case was aborted.Neither the double curve was nor the wds were introduced to the patient.Patient did not sustain any neurological or cardiovascular deficits.
Event or Problem Description
It was reported that a thrombus occurred.A watchman access system (was) single curve was positioned and a 24 mm watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.The was was positioned and prior to introducing the wds, the physician decided to exchange the single curve was for a double curve.At this time, the physician removed the device from the laa and introduced the pigtail catheter.Prior to inserting the new was, a large thrombus was noted just distal to the ostium of the laa.Immediately, the single curve was was removed from the patient and the case was aborted.Neither the double curve was nor the wds were introduced to the patient.Patient did not sustain any neurological or cardiovascular deficits.It was later reported, the single curve was was still in the patient when the thrombus was seen.After observing the thrombus, the sheath was then removed and the case was aborted.There were no interventions performed to manage the thrombus in the cath lab; instead, patient was started on anti-coagulants post-procedure to resolve the thrombus.Patient has not yet had a follow-up tee to determine the status of the thrombus.No other patient complications were reported.Patient was discharged without delay and is doing well.

• 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: 8179525
• Report Number: 2134265-2018-64439
• Device Sequence Number: 13932107
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/17/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0022778303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention