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

Model Number	M635TU70040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation, pericardial effusion, and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was performed.No pericardial effusion was noted pre-procedure.After multiple attempts of deploying a 24mm watchman flx closure device with a double curve watchman access system (was), it was decided to switch to an anterior curve watchman access system to obtain more anterior depth.A new 24mm watchman flx device was also used.The was was advanced into the laa and the unsheathing method was used to deploy the device, however, echocardiography confirmed the device was deployed too deep.A partial recapture was attempted and upon pulling back the sheath, a large pericardial effusion was noted on the anterior wall.A perforation was caused by the was going through the laa, but this was not realized until after the recapture and repositioning attempt for the second deployment with the device being deployed via the hole created by the was.A cardiac tamponade was also noted.An unsuccessful pericardiocentesis was attempted in which the physician punctured the patient's lung during this attempt.After multiple attempts, a drain was successfully placed and 1900cc of fluid was removed from the pericardial space.A code was called and chest compressions were performed on the patient.Once the patient was stable enough to transport to the operating room, the surgeon performed open heart surgery to suture the perforation in the laa and a clip was placed upon completion of the surgery.As of 20 april 2021, the patient was stable and extubated in the hospital.
Additional Manufacturer Narrative
H6: patient codes: added cardiac arrest.
Event or Problem Description
It was reported that a perforation, pericardial effusion, cardiac arrest, and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was performed.No pericardial effusion was noted pre-procedure.After multiple attempts of deploying a 24mm watchman flx closure device with a double curve watchman access system (was), it was decided to switch to an anterior curve watchman access system to obtain more anterior depth.A new 24mm watchman flx device was also used.The was was advanced into the laa and the unsheathing method was used to deploy the device, however, echocardiography confirmed the device was deployed too deep.A partial recapture was attempted and upon pulling back the sheath, a large pericardial effusion was noted on the anterior wall.A perforation was caused by the was going through the laa, but this was not realized until after the recapture and repositioning attempt for the second deployment with the device being deployed via the hole created by the was.A cardiac tamponade was also noted.An unsuccessful pericardiocentesis was attempted in which the physician punctured the patient's lung during this attempt.After multiple attempts, a drain was successfully placed and 1900cc of fluid was removed from the pericardial space.A code was called and chest compressions were performed on the patient.Once the patient was stable enough to transport to the operating room, the surgeon performed open heart surgery to suture the perforation in the laa and a clip was placed upon completion of the surgery.As of 20 april 2021, the patient was stable and extubated in the hospital.

• Brand Name: WATCHMAN TRUSEAL 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: 11778636
• Report Number: 2134265-2021-05173
• Device Sequence Number: 19891368
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0026348503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR