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

Model Number M635TU70020

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Event Description

It was reported that the access sheath shifted an ivc filter.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used.The physician inserted the was and was advancing the sheath into the patient when it shifted an ivc filter that was present in the patient.The physician consulted a vascular surgeon before the decision was made to continue the procedure.The procedure was continued and finished successfully.The closure device was implanted in the laa of the patient.There were no complications or deficits as a result of this event.The patient was doing fine following the procedure.

Event Description

It was reported that the access sheath shifted an ivc filter.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used.The physician inserted the was and was advancing the sheath into the patient when it shifted an ivc filter that was present in the patient.The physician consulted a vascular surgeon before the decision was made to continue the procedure.The procedure was continued and finished successfully.The closure device was implanted in the laa of the patient.There were no complications or deficits as a result of this event.The patient was doing fine following the procedure.It was further reported that the patient had an ivc stent not a filter.In addition the physician compared ct scans two months prior to watchman procedure to the procedural imaging and realized that the filter did not move.

• Brand Name: WATCHMAN TRUSEAL ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10328471
• MDR Text Key: 200606299
• Report Number: 2134265-2020-09732
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0024795192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other