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 Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/06/2021

Event Type  Injury  

Event Description

It was reported that a perforation, pericardial effusion and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.A double curve watchman truseal access system (was) was positioned and a 24mm watchman flx laa closure device & delivery system (wds) were used.There was trace amount of fluid noted in the transverse sinus but otherwise no pericardial effusion was noted before the procedure.The 24mm watchman flx device was implanted with just one deployment, and no recaptures or partial recaptures were performed.Sweeps were performed before device deployment and after release criteria was checked.The effusion was noted after release criteria was discussed.After the device was implanted the patient's blood pressure dropped, heart rate increased and there was some right atrium collapse and a large pericardial effusion was noted posterior to the heart near the left ventricle and left atrium.With time the perforation was noted on transesophageal echo (tee) imaging to be in the laa.Initially a pericardiocentesis was performed to manage the pericardial effusion.Once it became clear that the perforation was not going to seal or clot off the patient was taken to surgery.Surgery was performed and three sutures were used to repair the perforation.The watchman flx device remains implanted.The patient did well and was expected to be discharged a few days post surgery.It remains unclear when exactly the perforation occurred but most likely it seemed to have happened during the time of the was entry into the left atrium/laa and pigtail catheter entry into the left atrium/laa.

• 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: 12385761
• MDR Text Key: 268730599
• Report Number: 2134265-2021-10944
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M635TU70020
• Device Catalogue Number: M635TU70020
• Device Lot Number: 0027360995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR