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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 0025235568
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); ST Segment Elevation (2059)
Event Date 06/23/2020
Event Type  Injury  
Event Description
It was reported st elevation occurred.A left atrial appendage (laa) closure procedure was being performed.An non-bsc wire was inserted into the patient.Then a watchman truseal access system (was) was inserted into the patient and positioned into the laa.Prior to inserting the pigtail catheter into the patient, st elevation occurred.Coronary angiography of the lca and rca was performed and 5000 units of heparin were administered.Before inserting the 20mm watchman flx laa closure device with delivery system (wds), another st elevation occurred with bradycardia and blood pressure drop.The patient was stabilized with atropine and the was was withdrawn to the right.The patient continued to decline and cardiopulmonary resuscitation was performed for 30 minutes.Echocardiographic akinesia of the hw and massive right heart stress occurred.The coronary arteries are open with up to 60% stenosis in 3 ge.The rca is dominant with thrombolysis in myocardial infarction (timi) iii.The patient was sent to the intensive care unit where they became stable.Echocardiography was normal again.The patient was extubated on the following day.The patient was hemodymically stable and neurologically stable.The patient was discharged from the clinic and is in rehabilitation.An exact cause of the st elevation could not be determined, but it was suspected to be caused from an embolic insult.
 
Manufacturer Narrative
Returned device consisted of a watchman truseal access system.The device was bloody.Analysis of the tip and sheath included microscopic and visual inspection.Inspection revealed the tip was inverted, and there were numerous kinks in the sheath.Inspection of the rest of the device found no other damage or defect.The reported st elevation and cardiac arrest could not be confirmed as clinical circumstances could not be replicated.
 
Event Description
It was reported st elevation occurred.A left atrial appendage (laa) closure procedure was being performed.An non-bsc wire was inserted into the patient.Then a watchman truseal access system (was) was inserted into the patient and positioned into the laa.Prior to inserting the pigtail catheter into the patient, st elevation occurred.Coronary angiography of the lca and rca was performed and 5000 units of heparin were administered.Before inserting the 20mm watchman flx laa closure device with delivery system (wds), another st elevation occurred with bradycardia and blood pressure drop.The patient was stabilized with atropine and the was was withdrawn to the right.The patient continued to decline and cardiopulmonary resuscitation was performed for 30 minutes.Echocardiographic akinesia of the hw and massive right heart stress occurred.The coronary arteries are open with up to 60% stenosis in 3 ge.The rca is dominant with thrombolysis in myocardial infarction (timi) iii.The patient was sent to the intensive care unit where they became stable.Echocardiography was normal again.The patient was extubated on the following day.The patient was hemodymically stable and neurologically stable.The patient was discharged from the clinic and is in rehabilitation.An exact cause of the st elevation could not be determined, but it was suspected to be caused from an embolic insult.
 
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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 Key10314466
MDR Text Key200064508
Report Number2134265-2020-09817
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 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/19/2023
Device Lot Number0025235568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Date Manufacturer Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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