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

Lot Number 0024259233

Device Problem Gas/Air Leak (2946)

Patient Problems Air Embolism (1697); Bradycardia (1751); ST Segment Elevation (2059)

Event Date 06/23/2020

Event Type  Injury  

Event Description

It was reported that an air embolism with st elevation occurred.A left atrial appendage (laa) closure procedure was being performed.Successful transseptal puncture in a posterior interior position was performed.The physician then changed to the amplatz super stiff guidewire and inserted it into the pulmonary vein.A watchman truseal access system (was) was prepared and then positioned into the left atrium.The side connection of the was connected to the fluid line successfully.At this point, the patient's mean la pressure was 10mmhg and heparin was administered.A 27mm watchman flx laa closure device with delivery system (wds) was attempted.The closure device was deployed, but required three partial recaptures and was eventually fully recaptured since it did not meet the release criteria.A 24mm wds was chosen and attempted, but required four partial recaptures and was eventually fully recaptured since it did not meet the release criteria.The was repositioned and another 24mm wds was chosen and attempted, but was eventually fully recaptured since it did not meet the release criteria.The physician changed to an anterior curve was and successfully positioned it in the laa.Another 27mm wds was being prepared.After retrieving the 5f unknown pigtail catheter, air was noticed in the was and into the patient's left atrium.Slight st elevation was noticed on the electrocardiogram (ecg).Air was visible in the laa and the patient's heart rate dropped to 30 beat per minute.The patient's blood pressure and oxygen were stable at all times.Air was noticed in the right coronary artery (rca) and no other coronary artery.The patient was intubated and the rca was aspirated.The procedure was stopped at this point and the patient was transferred to the intensive care unit in good condition.The patient has completely recovered with no issues.

• 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: 10273306
• MDR Text Key: 198863435
• Report Number: 2134265-2020-09302
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Lot Number: 0024259233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention