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

Model Number 10371

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 12/06/2019

Event Type  Injury  

Event Description

It was reported a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.The transeptal puncture was performed.Two watchman access systems (was) and two 24mm watchman laa closure device and delivery systems (wds) were attempted to be used during the procedure.The first was and wds were used and removed from the patient.While preparing the 2nd was and 2nd wds, a pericardial effusion measuring 1.5cm was noticed.The was and wds were not in the patient when the pericardial effusion was noticed.The patient's blood pressure dropped and the procedure was aborted.The patient's activated clotting time was 246.A pericardiocentesis was performed and reversal agents were given.The total blood loss was 350ml.The patient stabilized and no blood was given.The patient was sent to the intensive care unit with a drain to be observed overnight.Echocardiogram evaluation showed the patient was stable on multiple repeat echocardiograms over the following hour.The patient was doing well and was expected to be discharged about a week post procedure.It was noted that the physician believed the pericardial effusion happened at the transeptal crossing.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9488735
• MDR Text Key: 171895760
• Report Number: 2134265-2019-15928
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024334273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention