MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number M635TU20060

Device Problems Leak/Splash (1354); Difficult to Open or Close (2921)

Patient Problem Blood Loss (2597)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported a valve leak occurred and the patient had a blood transfusion.A left atrial appendage (laa) closure procedure was being performed.The patient was noted to have very low hemoglobin prior to the start of the procedure.A watchman® access system (was) was used.The physician indicated the valve did not close initially, but after it was loosened and rethreaded it worked.The hemostasis valve on the (was) was noted to be leaking blood.The leakage was not excessive or out of the ordinary.However, the physician opted to change to another was to complete the procedure.Sometime post procedure the patient required a blood transfusion of 2 units of red blood cells.There were no further patient complications reported and the patient was reported as stable.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6511784
• MDR Text Key: 73382521
• Report Number: 2134265-2017-03887
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: (01)08714729838203(17)20190907(10)19687873
• 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: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2019
• Device Model Number: M635TU20060
• Device Catalogue Number: TU2006
• Device Lot Number: 19687873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention