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

Lot Number 0023303054

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

Patient Problems Death (1802); Pericardial Effusion (3271)

Event Date 06/13/2019

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

It was reported a pericardial effusion and patient death occurred.A left atrial appendage (laa) closure procedure was being performed.The patient was on eliquis.The trans-septal puncture was performed and 8000 units of heparin were administered.A watchman truseal access system (was) was positioned into the laa with a pigtail catheter.Contrast injections and transesophageal echocardiogram measurements were performed.A 21mm watchman laa closure device and delivery system (wds) was advanced into the was.At this time, the operating table was repositioned to get a better view of the laa anatomy.The closure device was deployed, but it was too deep in the laa, so a partial recapture was performed.The closure device was deployed again but was still too deep in the laa.Angiography revealed contrast in the pericardium.The patient was hemodynamically stable, so the procedure continued.A partial recapture was performed and the closure device was redeployed in correct position.The release criteria were met, so the closure device was successfully implanted.The size of the pericardial effusion was.9cm.The physician decided to perform a pericardiocentesis.The blood was aspirated via the pigtail catheter and re-infused into the patient.The activated clotting time was measured at 177 seconds.The bleeding did not stop, so the patient was transferred to cardiac surgery and was hemodynamically stable.Surgery was successfully performed.The closure device was removed and the laa was ligated.After the procedure, the physician reviewed the angiography images and believed it was the was that probably injured the laa wall while the operating table was moved.One day post procedure, the patient died of kidney failure.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8780522
• MDR Text Key: 150703148
• Report Number: 2134265-2019-07792
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• Device Lot Number: 0023303054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death