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

Model Number M635TU70040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 09/02/2020

Event Type  Injury  

Event Description

It was reported that a perforation and a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm watchman flx laa closure device & delivery system (wds) were used.The was was positioned in the laa and the wds was advanced into it.The closure device was deployed and successfully implanted in the laa of the patient.After the device was released it was noted that the patient had a pericardial effusion on the right side of their heart.The physician performed a pericardiocentesis and drained 405cc of fluid from the effusion.The patient did well following this treatment and is in good condition while recovering.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10589400
• MDR Text Key: 208624465
• Report Number: 2134265-2020-12963
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0025444368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR