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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 0022301175
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 11/13/2018
Event Type  Injury  
Event Description
It was reported a perforation and pericardial effusion with tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.The oxygen content of the patient was at 100% and 10,000 units of heparin were given.Trans-septal access was performed and they advanced a watchman truseal access system into the left upper pulmonary vein.Then a non-bsc pigtail catheter was inserted and advanced to the laa with the tip of the access system was at the entrance of the laa.The patient then became unstable and a pericardial effusion was noticed on the transesophageal echocardiogram (tee).A pericardial puncture was performed and approximately half a liter of blood was aspirated.It was noted that the blood was dark red in color and had an oxygen content of 65%, so it was concluded that it was venous blood not atrial blood.Therefore, they believed that the pericardial effusion occurred during the trans-sepal puncture.After about an hour, no more blood was able to be aspirated, so the patient was sent to the intensive care unit.However, it was reported the patient experienced tamponade with onset of cardiogenic shock and persistent bleeding (>1000ml cumulatively) into the pericardium despite administration of protamine, therefore, surgery was required.It was noted there was a small perforation in the area of the laa.The laa was clipped and the bleeding stopped.The patient was stable and no further complications were reported.It was further reported that the patient was in cardiac rehab and is doing fine.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the watchman truseal access system (was) with a dilator snapped into the sheath.The device was bloody.The hub, sheath, and tip were microscopically and visually inspected.Inspection found no damage or irregularities with the device.
 
Event Description
It was reported a perforation and pericardial effusion with tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.The oxygen content of the patient was at 100% and 10,000 units of heparin were given.Trans-septal access was performed and they advanced a watchman truseal access system into the left upper pulmonary vein.Then a non-bsc pigtail catheter was inserted and advanced to the laa with the tip of the access system was at the entrance of the laa.The patient then became unstable and a pericardial effusion was noticed on the transesophageal echocardiogram (tee).A pericardial puncture was performed and approximately half a liter of blood was aspirated.It was noted that the blood was dark red in color and had an oxygen content of 65%, so it was concluded that it was venous blood not atrial blood.Therefore, they believed that the pericardial effusion occurred during the trans-sepal puncture.After about an hour, no more blood was able to be aspirated, so the patient was sent to the intensive care unit.However, it was reported the patient experienced tamponade with onset of cardiogenic shock and persistent bleeding (>1000ml cumulatively) into the pericardium despite administration of protamine, therefore, surgery was required.It was noted there was a small perforation in the area of the laa.The laa was clipped and the bleeding stopped.The patient was stable and no further complications were reported.It was further reported that the patient was in cardiac rehab and is doing fine.
 
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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 Key8155464
MDR Text Key130072791
Report Number2134265-2018-63453
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/25/2021
Device Lot Number0022301175
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2018
Date Manufacturer Received12/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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