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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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BOSTON SCIENTIFIC CORPORATION WATCHMAN TRUSEAL ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL Back to Search Results
Lot Number 0024382739
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Cardiac Arrest (1762); ST Segment Elevation (2059)
Event Date 03/10/2020
Event Type  Injury  
Event Description
It was reported st elevation and air embolism occurred.A left atrial appendage (laa) closure procedure was being performed.The trans-septal puncture was performed and then the watchman truseal access system was used.There was no blood reflux when the dilator was withdrawn.The hemostasis valve was opened a little more.At this time, the patient inhaled deeply.After 20 seconds, st elevation was noticed on the electrocardiogram (ekg) and an air embolism occurred.After a few minutes, the patient became unstable and went into cardiac arrest.The patient was given catecholamines and resuscitation was performed.The patient was intubated and also defibrillated.After all of this, the patient was sent to the intensive ward and placed on extracorporeal membrane oxygenation (ecmo).No closure device was implanted.Two days post procedure, the patient was considered stable.
 
Event Description
It was reported st elevation and air embolism occurred.A left atrial appendage (laa) closure procedure was being performed.The trans-septal puncture was performed and then the watchman truseal access system was used.There was no blood reflux when the dilator was withdrawn.The hemostasis valve was opened a little more.At this time, the patient inhaled deeply.After 20 seconds, st elevation was noticed on the electrocardiogram (ekg) and an air embolism occurred.After a few minutes, the patient became unstable and went into cardiac arrest.The patient was given catecholamines and resuscitation was performed.The patient was intubated and also defibrillated.After all of this, the patient was sent to the intensive ward and placed on extracorporeal membrane oxygenation (ecmo).No closure device was implanted.Two days post procedure, the patient was considered stable.It was further reported that the patient was discharged from the hospital after recovering without neurological issues.
 
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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
MDR Report Key9941628
MDR Text Key187891276
Report Number2134265-2020-04261
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/04/2022
Device Lot Number0024382739
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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