MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number 10371

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Event Description

It was reported that there was difficulty in trying to recapture the closure device.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 30mm watchman laa closure device & delivery system (wds) were used.The was positioned in the laa of the patient.The first closure device was deployed in the laa, but did not meet release criteria and was fully recaptured.A second closure device was deployed using the same was and again this device did not meet release criteria and needed to be fully recaptured.During the recapture of this device the physician struggled to get the feet back into the was.The shoulders and anchors would not come through into the sheath.After much effort and more resistance felt the physician was able to recapture the device and remove it from the patient.The was removed from the patient as well and no damage was noted to it.A new was inserted into the patient and positioned in the laa.A new 30mm closure device was successfully implanted in the patient.After the procedure was completed the patient returned to the post anesthesia care unit with chest tightness.The patient became hypotensive as well.The patient was evaluated with a transthoracic echocardiogram and a pericardial effusion was found.The physician tapped the patient at this time to drain the effusion.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8917632
• MDR Text Key: 155105582
• Report Number: 2134265-2019-09909
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023225612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1