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

Model Number M635TU70020

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

Patient Problem Pericardial Effusion (3271)

Event Date 07/22/2021

Event Type  Injury  

Event Description

It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal access system (was) was positioned and a 27mm watchman flx laa closure device & delivery system (wds) were used.After the transseptal puncture (tsp), a small pericardial effusion around 2-3mm was noted and monitored.The patient had a stable blood pressure and the effusion was not growing, so the case continued and a 27mm device was successfully implanted.The patient was monitored on the table for 30 minutes post procedure before the physician decided to perform a pericardiocentesis and put in a pericardial drain as the effusion had grown.Around 800-1000ml of blood was removed.When gaining access to the pericardium to put in a pericardial drain, the physician inadvertently hit a epicardial vein of the right ventricle.The original pericardial effusion from the tsp had stopped, but this new source of bleeding needed surgical intervention and patch repair.The patient is reported to be stable, but is still recovering in the hospital under the care of the surgical team.

• 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: 12308303
• MDR Text Key: 266045701
• Report Number: 2134265-2021-10247
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729965718
• UDI-Public: 08714729965718
• 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: 08/11/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2024
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0027454531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention