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

Lot Number 0025375719

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

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)

Event Date 02/25/2021

Event Type  Injury  

Event Description

(b)(6) study.It was reported that air embolism with st segment elevation occurred.On (b)(6) 20201 a left atrial appendage (laa) closure procedure was performed.A concomitant ablation using the pulmonary vein isolation ablation and radiofrequency (rf)-point by point technique was also performed.During the watchman procedure, no air was seen, but transient inferior st segment elevations were present after introducing the watchman truseal access sheath.It was speculated, that air was "sucked in" when the truseal and the dilator were in the left atrium across the guidewire and the patient took a deep breath.There is no valve on the dilator and the valve of the truseal was not completely tight because the dilator was in place.A puncture of the right femoral artery was done for coronary angiography with coronary occlusions ruled out.There was spontaneous normalization of the electrocardiogram (ecg).The procedure continued and the patient underwent successful placement of a 24 mm watchman flx closure device with complete laa seal and deployed device diameter of 21 mm.On (b)(6) 2021, the patient was discharged home on aspirin and nonsteroidal anti-inflammatory drugs (nsaids).

• 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: 11486825
• MDR Text Key: 240025619
• Report Number: 2134265-2021-03121
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Lot Number: 0025375719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR